TRVN Trevena Inc.

2.4
+0.03  (+1%)
Previous Close 2.37
Open 2.38
52 Week Low 0.46
52 Week High 3.68
Market Cap $376,872,029
Shares 157,030,012
Float 155,924,805
Enterprise Value $289,431,330
Volume 2,392,952
Av. Daily Volume 5,446,872
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Upcoming Catalysts

Drug Stage Catalyst Date
TRV027
COVID-19
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
Oliceridine (TRV130)
Moderate to severe acute pain
Approved
Approved
FDA Approval announced August 7, 2020.
TRV250
Acute migraine
Phase 1
Phase 1
Phase 1 enrolment has been paused due to COVID-19 - noted March 26. 2020.
TRV734
Opioid use disorder
Phase 2
Phase 2
Proof of concept trial initiation announced December 23, 2019.
TRV027 - BLAST-AHF
Acute heart failure
Phase 2a
Phase 2a
Phase 2b endpoints not met - May 2016

Latest News

  1. --

    OLINVYK significantly reduced risk of vomiting and rescue antiemetic use compared to IV morphine in a retrospective analysis

    --

    CHESTERBROOK, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a publication, titled "Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials," with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group (DOI: https://doi.org/10.1007/s40122-020-00216-x

    --

    OLINVYK significantly reduced risk of vomiting and rescue antiemetic use compared to IV morphine in a retrospective analysis

    --

    CHESTERBROOK, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a publication, titled "Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials," with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group (DOI: https://doi.org/10.1007/s40122-020-00216-x).

    The results of this analysis highlight an improved gastrointestinal (GI) tolerability profile, with OLINVYK demonstrating a ~2-3x likelihood of achieving a "complete GI response" compared to IV morphine under equianalgesic conditions. A complete GI response is defined as the proportion of patients who complete the study without vomiting and without using any antiemetics.

    "There are multiple types of procedures where post-operative nausea or vomiting can disrupt the integrity of a surgery, posing a significant challenge to a patient's recovery," said Tim Beard, M.D. "Based on the results of this analysis, OLINVYK has the potential to greatly reduce the risk of nausea and vomiting following surgery, compared to IV morphine. These are compelling findings that suggest the clinical advantages OLINVYK may offer in the post-operative acute care setting."

    Publication Key Points:

    • Orthopedic surgery-bunionectomy study: A higher proportion of patients achieved ‘complete GI response' with all OLINVYK treatment regimens (0.1 mg: 76.3%; 0.35 mg: 53.2%; 0.5 mg: 49.4%) compared to IV morphine (32.9%; p < 0.05 for all 3 OLINVYK dose regimens).
    • Plastic surgery-abdominoplasty study: A higher proportion of patients achieved ‘complete GI response' with all OLINVYK treatment regimens (0.1 mg: 59.7%; 0.35 mg: 39.2%; 0.5 mg: 29.9%) compared to IV morphine (28.8%; p ≤ 0.0001 for OLINVYK 0.1 mg).
    • Pooled data from both trials: There was a statistically significantly higher rate of ‘complete GI response' associated with OLINVYK 0.1 mg (68%) and 0.35 mg (46.2%) compared to IV morphine (30.8%; p ≤ 0.005).
    • Under equianalgesic conditions: Where analgesia as measured by Sum of Pain Intensity Difference (SPID) scores was held constant, patients were 3.1x more likely to achieve a ‘complete GI response' with OLINVYK than IV morphine in the orthopedic surgery-bunionectomy study (95% CI: 1.78, 5.56; p <0.0001), and 1.9x more likely in the plastic-surgery abdominoplasty study (95% CI: 1.09, 3.36; p = 0.024).

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and single bolus doses greater than 3 mg have not been evaluated. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840



    Primary Logo

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  2. --

    Guggenheim Healthcare Talks - 2nd Annual Neuro/Immunology Day Conference
    November 16th

    Stifel Virtual Healthcare Conference
    November 18th

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    CHESTERBROOK, Pa., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that management will participate in the following conferences in the month of November and invites investors to participate by webcast. Please see additional details below:

    Guggenheim Healthcare Talks - 2nd Annual Neuro/Immunology Day   
     Date:Monday, November 16th, 2020
     Format:One-on-One meetings with Trevena Management &
      Analyst-moderated panels
     Attendees:

    --

    Guggenheim Healthcare Talks - 2nd Annual Neuro/Immunology Day Conference

    November 16th



    Stifel Virtual Healthcare Conference

    November 18th

    --

    CHESTERBROOK, Pa., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that management will participate in the following conferences in the month of November and invites investors to participate by webcast. Please see additional details below:

    Guggenheim Healthcare Talks - 2nd Annual Neuro/Immunology Day   
     Date:Monday, November 16th, 2020
     Format:One-on-One meetings with Trevena Management &
      Analyst-moderated panels
     Attendees:Carrie Bourdow, President & CEO
      Barry Shin, Senior Vice President & Chief Financial Officer
       
    Stifel Virtual Healthcare Conference 
     Date:Wednesday, November 18th, 2020
     Format:Corporate Presentation
     Time:4:40 - 5:10 pm Eastern Time
     Attendees:Carrie Bourdow, President & CEO
      Barry Shin, Senior Vice President & Chief Financial Officer
      Mark A. Demitrack, MD, Senior Vice President & Chief Medical Officer

    Any replay or webcast will be made available when possible, via the Events page of the Investors section on the Company's website at www.Trevena.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC

     

    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

    Primary Logo

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  3. --

    OLINVYK commercial supply on track and available in November

    Company funded through Q4 2022, including OLINVYK commercialization

    --

    Company to host conference call at 8:30 a.m. ET on Monday, November 2nd, 2020

    --

    CHESTERBROOK, Pa., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that oliceridine has been classified as a Schedule II controlled substance by the U.S. Drug Enforcement Administration (DEA). With DEA scheduling now complete, the Company expects to make OLINVYK available for distribution in November.

    "I am pleased that OLINVYK is now an…

    --

    OLINVYK commercial supply on track and available in November

    Company funded through Q4 2022, including OLINVYK commercialization

    --

    Company to host conference call at 8:30 a.m. ET on Monday, November 2nd, 2020

    --

    CHESTERBROOK, Pa., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that oliceridine has been classified as a Schedule II controlled substance by the U.S. Drug Enforcement Administration (DEA). With DEA scheduling now complete, the Company expects to make OLINVYK available for distribution in November.

    "I am pleased that OLINVYK is now an FDA approved and scheduled product – two major milestones achieved in 2020," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "We made the decision earlier this year to begin manufacturing commercial product, so that physicians could have access to OLINVYK for their hospitalized acute pain patients as soon as possible upon approval and DEA scheduling. We look forward to making OLINVYK available for ordering in November."

    Each year, approximately 45 million hospital patients in the United States receive drugs like IV morphine to treat their acute pain. OLINVYK is an IV opioid that is the first new chemical entity in this drug class in decades and is distinct from drugs like IV morphine. OLINVYK has no active metabolites and requires no dosage adjustment in renal-impaired patients, a large patient population with significant medical complications. In addition, OLINVYK delivers IV opioid efficacy with a rapid 2-5 minute onset of action.

    OLINVYK was studied in over 1,500 patients, including medically complex patients such as the elderly and obese, and across a variety of surgical procedures.

    As a new chemical entity, OLINVYK was required to be scheduled by the DEA following its approval by FDA in August 2020. A Schedule II assignment applies to drugs that should only be administered by a healthcare professional in controlled clinical settings. All current IV opioids used in the hospital setting are classified as Schedule II substances.

    The Company also today announced cash and cash equivalents of $112.7 million as of September 30, 2020, which the Company expects will be sufficient to fund operating expenses, including the commercialization of OLINVYK, through year-end 2022.

    Conference Call and Webcast Information

    The Company will host a conference call and webcast with the investment community on Monday, November 2nd, 2020, at 8:30 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Robert Yoder, Chief Commercial Officer, Mark Demitrack, M.D., Chief Medical Officer, and Barry Shin, Chief Financial Officer.

    Title:Conference Call to Provide Update on Commercial Launch Activities for OLINVYK
    Date:Monday, November 2nd, 2020
    Time:8:30 a.m. ET
    Conference

    Call Details:
    Toll-Free: 1-877-451-6152

    International: 1-201-389-0879

    Conference ID: 13712808
    Webcast:https://www.trevena.com/investors/events-presentations/ir-calendar

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Commercial Officer

    Trevena, Inc.

    (610) 354-8840

     

    Primary Logo

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  4. --

    Posters highlight improvements in respiratory safety and gastrointestinal tolerability associated with OLINVYK (oliceridine) injection vs. IV morphine

    --

    CHESTERBROOK, Pa., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced three presentations at ANESTHESIOLOGY® 2020, the national conference for the American Society of Anesthesiologists (ASA). The conference was held virtually from October 2nd to 7th, 2020. The presentations included three posters, all of which discussed new analyses of data from the OLINVYK Phase 3 program.

    "Throughout its clinical development…

    --

    Posters highlight improvements in respiratory safety and gastrointestinal tolerability associated with OLINVYK (oliceridine) injection vs. IV morphine

    --

    CHESTERBROOK, Pa., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced three presentations at ANESTHESIOLOGY® 2020, the national conference for the American Society of Anesthesiologists (ASA). The conference was held virtually from October 2nd to 7th, 2020. The presentations included three posters, all of which discussed new analyses of data from the OLINVYK Phase 3 program.

    "Throughout its clinical development, OLINVYK has demonstrated a consistently favorable side effect profile," said Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. "I am pleased that we are still gaining valuable clinical insights into its differentiated profile as we continue to examine the robust Phase 3 data, which is clearly of great interest to clinicians looking for alternative treatment options for the treatment of acute pain."

    Poster Details

    1. (Poster #A4280) "Evaluating Predictive Value Of Postoperative O2 Saturation Levels To Rate Of Respiratory Safety Events In Oliceridine Trials," with lead author Sabry Ayad, M.D., Department of Anesthesiology at Cleveland Clinic.

    • OLINVYK demonstrated an overall lower incidence of respiratory safety events (RSEs) (12.8% - 13.8%) compared with IV morphine (22.8% - 23.4%) in Phase 3 randomized controlled trials (RCTS) in orthopedic and plastic surgeries.
    • In these OLINVYK Phase 3 RCTs, respiratory safety was assessed using a predefined RSE measure. An analysis was conducted to determine the correlation between RSEs and oxygen saturation (SpO2) < 90%, a known independent risk factor of early postoperative respiratory complications and resource utilization.
    • The analysis showed that SpO2 < 90% was predictive of an RSE and may serve as a valuable objective measure within a health economic model for OLINVYK.

    2. (Poster #A4281) "Improved Tolerability With Oliceridine Compared To Morphine At Equianalgesic Doses," with lead author Gregory Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University. 

    A secondary analysis was conducted on the data from the OLINVYK Phase 3 pivotal RCTs in order to evaluate the safety of OLINVYK, compared to IV morphine, when adjusted for equal levels of analgesia. A composite safety endpoint was defined using the adverse events (AEs) that occurred in ≥ 10% of patients who received either OLINVYK or IV morphine (nausea, vomiting, sedation, dizziness, pruritus, and hypoxia). The incidence of the individual AEs was also assessed.

    • Following orthopedic surgery, OLINVYK demonstrated a significantly lower odds ratio (p < 0.05) for rates of nausea, vomiting, and pruritus, compared to IV morphine.
    • Following plastic surgery, OLINVYK demonstrated a significantly lower odds ratio (p < 0.05) for rates of nausea, vomiting, and sedation compared to IV morphine.
    • At equianalgesic levels, OLINVYK's odds ratio for the composite safety endpoint was approximately half of that associated with IV morphine. The findings were consistent across both studies.

    3. (Poster #A4284) "Reduced Incidence Of Postoperative Vomiting With Oliceridine Than Morphine At Equianalgesic Doses," with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group. 



    A retrospective analysis was conducted on the gastrointestinal (GI) tolerability data from the OLINVYK Phase 3 RCTs, using a ‘complete GI response' endpoint. A ‘complete GI response' is defined as the proportion of patients who complete the study without vomiting and without using any anti-emetics.

    • In both studies, OLINVYK 0.1 mg and 0.35 mg were associated with a significantly higher rate of ‘complete GI response' compared with IV morphine.
    • Under equianalgesic conditions, where analgesia as measured by Sum of Pain Intensity Difference (SPID) scores was held constant, the odds ratio for ‘complete GI response' was higher with OLINVYK than IV morphine.

    All posters can be found at https://www.trevena.com/publications.

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

     

    Primary Logo

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  5. --

    Live presentation highlighting TRV027 as a potential treatment for COVID-19 acute respiratory distress syndrome (ARDS) / abnormal clotting

    Posters on OLINVYK benefit-risk profile and TRV250 Phase 1 pharmacokinetics

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    CHESTERBROOK, Pa., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced three presentations at the virtual 2020 American College of Clinical Pharmacology (ACCP) Annual Meeting, taking place from September 21st to 23rd, 2020.

    The Company will give a live presentation on TRV027, its AT1 receptor selective agonist being studied as a potential…

    --

    Live presentation highlighting TRV027 as a potential treatment for COVID-19 acute respiratory distress syndrome (ARDS) / abnormal clotting

    Posters on OLINVYK benefit-risk profile and TRV250 Phase 1 pharmacokinetics

    --

    CHESTERBROOK, Pa., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced three presentations at the virtual 2020 American College of Clinical Pharmacology (ACCP) Annual Meeting, taking place from September 21st to 23rd, 2020.

    The Company will give a live presentation on TRV027, its AT1 receptor selective agonist being studied as a potential treatment for ARDS / abnormal clotting in COVID-19. Additionally, the Company will present two posters highlighting previously published data for OLINVYK, which is approved in the U.S. for the management of acute pain, and TRV250, its delta receptor selective agonist being developed for the acute treatment of migraine.

    "I am pleased at this opportunity to present compelling data from three of our programs. The interest from ACCP highlights the diversity of our novel pipeline, with multiple exciting catalysts over the next few months," said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc.

    Poster Presentation Details

    Live presentation: "The Use of Simulation in the Re-purposing of Drugs for COVID-19: The Example of TRV027" (8:00-9:30 a.m. ET, September 21st, 2020)

    • In a COVID-19 infection, the SARS-coronavirus-2 binds to and removes the ACE2 protein in the lungs and other organs, resulting in a hormonal imbalance of angiotensin 2 within the RAAS pathway, converging at the AT1 receptor.
    • There is significant interest in the potential utility of TRV027 in COVID-19 patients, given its unique mechanism of action at the AT1 receptor, which is known to mediate the effects of angiotensin 2 on lung damage and abnormal coagulation.
    • Simulations were conducted to determine potential therapeutic doses, which informed a proof-of-concept trial recently initiated by Imperial College London. The study will enroll 60 hospitalized, non-ventilated patients aged 18 or older with a confirmed COVID-19 infection. The primary objective of the study is to evaluate whether TRV027 reduces abnormal clotting associated with COVID-19.

    Poster presentation (#009): "Improved Safety of Opioid Analgesic Oliceridine Compared to Morphine Assessed by Utility Function Analysis" (4:00-6:00 p.m. ET, September 21st and 22nd, 2020)

    • OLINVYK was associated with a higher probability of analgesia than respiratory depression, while the reverse was true for morphine.
    • The clinical utility function model predicted there would be a lower probability of a respiratory event occurring with OLINVYK versus morphine.
    • Over the clinically relevant concentration range, OLINVYK had a higher probability of providing analgesia than producing respiratory depression, while morphine had a higher probability of producing respiratory depression than providing analgesia.

    Poster presentation (#022): "A Phase 1 Healthy Volunteer Study of the Safety, Tolerability and Pharmacokinetics of TRV250, a G Protein-Selective Delta Receptor Agonist" (4:00-6:00 p.m. ET, September 21st and 22nd, 2020)

    • TRV250 was well-tolerated up to 30 mg, with a PK profile appropriate for an acute migraine therapy.
    • There were no serious adverse events and no clinically significant changes in EEG, ECG, or other safety parameters.

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

    About TRV027

    TRV027 is a novel AT1 receptor selective agonist that has previously been studied in 691 individuals. It has demonstrated efficacy, potency, and selectivity at the AT1 receptor in nonclinical studies and has a well-characterized pharmacokinetic profile. In previous clinical trials, there was a low dropout rate associated with TRV027, and no significant safety issues were reported. In April 2020, the Company filed a provisional patent application with the United States Patent and Trademark Office covering the use of TRV027 to treat ARDS and the prevention or treatment of abnormal clotting in COVID-19 patients.

    About TRV250

    TRV250 is a G-protein selective agonist targeting the delta receptor, with potential to be a first-in-class, non-narcotic mechanism for the treatment of migraine. TRV250 also may have utility in a range of other central nervous system indications. As a selective delta receptor modulator, TRV250 is not expected to have the abuse and addiction liability of medications targeting the mu opioid receptor. TRV250 is an investigational product and has not been approved by FDA for distribution in the US.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

     

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