TRVN Trevena Inc.

1.25
-0.11  -8%
Previous Close 1.36
Open 1.34
52 Week Low 1.25
52 Week High 3.68
Market Cap $205,636,048
Shares 164,508,838
Float 163,341,823
Enterprise Value $128,712,754
Volume 2,329,138
Av. Daily Volume 2,407,948
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Upcoming Catalysts

Drug Stage Catalyst Date
OLINVYK (oliceridine)
Obesity
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
OLINVYK (oliceridine)
Moderate to severe acute pain
Approved
Approved
FDA Approval announced August 7, 2020.
TRV734
Opioid use disorder
Phase 2
Phase 2
Proof of concept trial has resumed following pause due to COVID-19 - June 16, 2021.
TRV027 (REMAP-CAP COVID-19 ACE2 RAS Modulation Domain)
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 trial ongoing.
TRV250
Acute migraine
Phase 1
Phase 1
Phase 1 enrolment has been paused due to COVID-19 - noted March 26. 2020.
TRV027 - BLAST-AHF
Acute heart failure
Phase 2a
Phase 2a
Phase 2b endpoints not met - May 2016

Latest News

  1. CHESTERBROOK, Pa., July 26, 2021 (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 the first COVID-19 patient has been enrolled in the NIH-funded ACTIV-4 Host Tissue (Accelerating COVID-19 Therapeutic Interventions and Vaccines) trial.

    "There is no one solution to end COVID-19, and we are honored to play a role in the global effort to overcome this pandemic and mitigate its long-term impact on our communities," said Carrie Bourdow, President and CEO of Trevena. "I am excited that patients are now being enrolled in this study and that TRV027 is the one of the first active…

    CHESTERBROOK, Pa., July 26, 2021 (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 the first COVID-19 patient has been enrolled in the NIH-funded ACTIV-4 Host Tissue (Accelerating COVID-19 Therapeutic Interventions and Vaccines) trial.

    "There is no one solution to end COVID-19, and we are honored to play a role in the global effort to overcome this pandemic and mitigate its long-term impact on our communities," said Carrie Bourdow, President and CEO of Trevena. "I am excited that patients are now being enrolled in this study and that TRV027 is the one of the first active treatment arms available for patient randomization."

    The trial, known as ACTIV-4 Host Tissue, is testing four investigational agents that combat dysregulation of the renin-angiotensin-aldosterone system (RAAS) and the immune system caused by a COVID-19 infection. TRV027 is a novel AT1 receptor selective agonist that specifically binds to and rebalances AT1 receptor activation within the RAAS, blocking the damaging pathway that leads to acute lung damage and abnormal blood clotting, while activating the cellular pathway that selectively targets reparative actions that improve lung function and promote anti-inflammatory effects.

    The trial is enrolling approximately 1,600 patients at over 50 sites in the U.S. TRV027 is part of the initial trial launch, and additional study arms will be added to the trial over time. The study is evaluating the impact of each intervention on recovery, supplemental oxygen use, need for mechanical ventilation, organ failure, and mortality.

    "As the COVID-19 pandemic continues to evolve, the development of interventions that can combat the vascular, fibrotic, and inflammatory damage done by the coronavirus remains a top priority," said Sean Collins, M.D., M.Sci., Principal Investigator of the ACTIV-4 Host Tissue trial, Co-Director of the Vanderbilt Coordinating Center and Professor of Emergency Medicine, Vanderbilt University Medical Center. "I am very pleased that we have enrolled our first patient in the ACTIV-4 Host Tissue trial, and I look forward to investigating the potential of TRV027 to modulate the RAAS and improve outcomes for patients hospitalized with COVID-19."

    About ACTIV-4 Host Tissue

    This is a multi-site, randomized, placebo-controlled, clinical trial with multiple treatment arms, each enrolling approximately 300-400 COVID-19 patients ≥ 18 years old. Four trial arms are testing investigational agents, including TRV027, that target the RAAS or the immune system through distinct mechanisms of action. The objective of the trial is to determine whether modulation of these systems is an effective strategy for preventing progression to critical illness, multiorgan failure, or mortality in hospitalized COVID-19 patients.

    The trial is funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the NIH.

    About the NIH ACTIV Initiative

    On April 17, 2020, the National Institutes of Health (NIH) announced the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines.



    Coordinated by the Foundation for the National Institutes of Health (FNIH), ACTIV brings NIH together with its sibling agencies in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA); other government agencies including the Department of Defense (DOD) and Department of Veterans Affairs (VA); The Operation; the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies.

    For more information about the ACTIV therapeutic trials, including ACTIV-4 Host Tissue, visit the ACTIV website: https://www.nih.gov/research-training/medical-research-initiatives/activ.

    About TRV027

    TRV027 is a novel AT1 receptor selective agonist that is currently being investigated by multiple institutions as a potential treatment for acute lung injury contributing to ARDS and abnormal blood clotting in COVID-19 patients. It has previously been studied in 691 individuals, has a well-characterized pharmacokinetic profile, and has demonstrated efficacy, potency, and selectivity at the AT1 receptor in nonclinical studies. In previous clinical trials, there was a low dropout rate associated with TRV027, and no significant safety issues were reported. TRV027 is currently being evaluated in the REMAP-CAP COVID-19 ACE2 RAS Modulation Domain, an international, multi-site, randomized, Phase 2 / 3 adaptive clinical trial in hospitalized COVID-19 patients. In April 2021, the Company filed a non-provisional patent application and PCT 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 Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative 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's novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic pain and epilepsy, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.

    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 and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and 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 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 FDA, the timing of FDA's decision on the oliceridine NDA; 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

    PR & Media Contact:

    Sasha Bennett

    Associate Vice President

    Clyde Group



    (239) 248-3409



    Primary Logo

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  2. CHESTERBROOK, Pa., July 23, 2021 (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 Glass Lewis and ISS, two independent, leading proxy advisory firms, have both recommended that Trevena shareholders vote "FOR" Proposals 1 & 2 set forth in its Definitive Proxy Statement filed with the Securities and Exchange Commission on July 6, 2021 in connection with its Special Meeting of Stockholders, which seek to amend Trevena's Amended and Restated Certificate of Incorporation to approve a Reverse Stock Split and concurrent Authorized Share Reduction. The Special Meeting will be…

    CHESTERBROOK, Pa., July 23, 2021 (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 Glass Lewis and ISS, two independent, leading proxy advisory firms, have both recommended that Trevena shareholders vote "FOR" Proposals 1 & 2 set forth in its Definitive Proxy Statement filed with the Securities and Exchange Commission on July 6, 2021 in connection with its Special Meeting of Stockholders, which seek to amend Trevena's Amended and Restated Certificate of Incorporation to approve a Reverse Stock Split and concurrent Authorized Share Reduction. The Special Meeting will be held on August 9, 2021 at 8:30 a.m. ET and will be held virtually at http://www.virtualshareholdermeeting.com/TRVN2021SM.

    "We greatly appreciate the third-party, independent recommendations from both Glass Lewis and ISS," said Carrie Bourdow, President and CEO of Trevena. "Trevena has had a transformational year and these proposals are key to positioning the company for continued long term growth, as detailed in our Proxy Statement."

    Glass Lewis and ISS are widely recognized as two of the leading independent proxy voting and corporate governance advisory firms. Their recommendations are relied upon by institutional investment firms, mutual funds, and other fiduciaries globally. Glass Lewis and ISS are independent proxy advisory firms and do not have any business relationship with Trevena. Trevena did not engage or compensate either firm for its analysis or recommendations.

    Trevena shareholders are urged to vote as Glass Lewis and ISS recommend by voting "FOR" the two proposals detailed below:

    • Proposal 1: Approval of a reverse stock split of our issued and outstanding shares of common stock at a ratio of one (1) share of common stock for every four (4) shares of common stock (the "Reverse Stock Split"), to be effected through an amendment to our amended and restated certificate of incorporation (as amended, the "Restated Certificate"); and



    • Proposal 2: Approval to decrease the number of authorized shares of common stock from 200,000,000 to 100,000,000 (the "Authorized Share Reduction"), contingent upon and concurrent with the Reverse Stock Split, to be effected through an amendment to the Restated Certificate.

    Shareholders with questions may call Alliance Advisors, LLC at 833-501-4709 or by email at .

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative 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's novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic pain and epilepsy, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.

    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:

    Sasha Bennett

    Associate Vice President

    Clyde Group



    (239) 248-3409



    Primary Logo

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  3. Models demonstrate substantial overall cost savings for hospitals when using OLINVYK compared to IV morphine in postoperative care

    CHESTERBROOK, Pa., July 12, 2021 (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 the publication of the health economic model for OLINVYK (oliceridine) injection in Journal of Comparative Effectiveness Research. The model estimates the budget impact of OLINVYK compared to IV morphine when used on-demand in a hospital setting for postoperative pain.

    The publication is titled, "Cost-effectiveness and Cost-benefit Analysis of Oliceridine in the…

    Models demonstrate substantial overall cost savings for hospitals when using OLINVYK compared to IV morphine in postoperative care

    CHESTERBROOK, Pa., July 12, 2021 (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 the publication of the health economic model for OLINVYK (oliceridine) injection in Journal of Comparative Effectiveness Research. The model estimates the budget impact of OLINVYK compared to IV morphine when used on-demand in a hospital setting for postoperative pain.

    The publication is titled, "Cost-effectiveness and Cost-benefit Analysis of Oliceridine in the Treatment of Acute Pain," with lead author Kit N. Simpson, DrPH, Professor of HealthCare Leadership and Management, College of Health Professions and Public Health, and Director, Comparative Effectiveness Data Analysis Resource (CEDAR) Core at Medical University of South Carolina (DOI: https://doi.org/10.2217/cer-2021-0107).

    "I am pleased to have the health economic model now in the published literature – a significant milestone that will continue to support the formulary review process for OLINVYK," said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena. "We have had multiple opportunities to present these compelling cost offset findings to the medical community, and the response from hospital decision makers has been consistently positive and very encouraging."

    As previously announced, the model calculates a significant decrease in total cost of care per 1,000 patients associated with OLINVYK, compared to IV morphine. These cost savings are due to potentially reduced adverse effect(s) (AEs) for OLINVYK-treated patients, as observed in the Phase 3 pivotal trials, and using AE cost estimates based on government and published literature sources.

    The publication can be found at https://www.trevena.com/publications. While the cost savings in these health economic models cannot be guaranteed, they are based on generally accepted methodology, and pharmacy and therapeutics committees typically review health economic models when making drug formulary decisions.

    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 doses greater than 3 mg should not be administered. 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 innovative 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's novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic pain and epilepsy, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.

    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

    PR & Media Contact:

    Sasha Bennett

    Director

    Clyde Group



    (239) 248-3409





    Primary Logo

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  4. Nhwa is conducting and funding this study to support NDA regulatory filing in China

    Trevena expects to receive approval and commercialization milestones, and a 10% royalty on net sales in China

    CHESTERBROOK, Pa., July 08, 2021 (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 the Company's partner in China has enrolled the first patient in a Phase 3 trial for OLINVYK (oliceridine) injection, a novel IV analgesic approved in the U.S. by the Food and Drug Administration (FDA) for acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments…

    Nhwa is conducting and funding this study to support NDA regulatory filing in China

    Trevena expects to receive approval and commercialization milestones, and a 10% royalty on net sales in China

    CHESTERBROOK, Pa., July 08, 2021 (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 the Company's partner in China has enrolled the first patient in a Phase 3 trial for OLINVYK (oliceridine) injection, a novel IV analgesic approved in the U.S. by the Food and Drug Administration (FDA) for acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

    "We are committed to delivering OLINVYK to patients and healthcare providers in need of alternative acute pain treatment options, both through our ongoing launch in the U.S. as well as our global partnerships," said Carrie Bourdow, President and CEO of Trevena. "I am pleased that Nhwa has reached this important clinical development milestone, and we look forward to supporting their efforts to secure regulatory approval of OLINVYK in China."

    This is a randomized, double-blind, active-controlled study that will enroll approximately 160 patients following abdominal surgery. The study includes an OLINVYK arm and an IV morphine positive control arm. The primary efficacy endpoint is the proportion of responders to study medication based on their pain numeric rating scale (NRS) at the end of the randomized 24-hour treatment period. Safety and tolerability will be assessed by respiratory depression adverse events (AEs), sedation AEs, the use of rescue antiemetics, clinician- and patient-reported satisfaction, and other measures. The study was developed based on feedback from the Chinese National Medical Products Administration (NMPA). Following study completion, Nhwa expects to have sufficient clinical data, accompanied by Trevena's existing clinical data, to submit OLINVYK for regulatory approval in China.

    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 doses greater than 3 mg should not be administered. 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 innovative 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's novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic pain and epilepsy, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.

    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 and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and 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 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 FDA, the timing of FDA's decision on the oliceridine NDA; 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

    PR & Media Contact:

    Sasha Bennett

    Associate Vice President

    Clyde Group



    (239) 248-3409 



    Primary Logo

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  5. --

    Study is evaluating the role of age and weight in a comparative analysis of the effect of OLINVYK and morphine on respiratory function

    Led by world-renowned research group, utilizing an innovative PK / PD clinical utility function analysis method

    Enrollment expected to begin in Q3 2021; topline data expected by YE 2021

    --

    CHESTERBROOK, Pa., July 07, 2021 (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 it has initiated a new study evaluating the physiologic impact of OLINVYK on respiratory function in elderly / obese subjects.

    This latest study is being led by Albert…

    --

    Study is evaluating the role of age and weight in a comparative analysis of the effect of OLINVYK and morphine on respiratory function

    Led by world-renowned research group, utilizing an innovative PK / PD clinical utility function analysis method

    Enrollment expected to begin in Q3 2021; topline data expected by YE 2021

    --

    CHESTERBROOK, Pa., July 07, 2021 (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 it has initiated a new study evaluating the physiologic impact of OLINVYK on respiratory function in elderly / obese subjects.

    This latest study is being led by Albert Dahan, M.D., Ph.D., Professor of Anesthesiology at the Leiden University Medical Center and a leading clinical researcher on the effects of opioid medications on respiratory physiology in humans. This study expands upon previously published work that the Company reported in collaboration with Dr. Dahan's research team. That work used clinical utility function analysis methodology based on the original OLINVYK Phase 1 ventilatory response to hypercapnia (VRH) data. Clinical utility function analysis is a novel method used in various scientific areas of research that integrates multiple physiologic inputs into a single integrated output function, as a method of estimated risk and benefit. In this study, the integrated inputs of interest are analgesia (benefit) and respiratory depression (risk).

    "Clinical utility function analysis offers an objective and precise way to quantitatively assess the effect of different drugs on multiple outcomes, such as analgesia and respiratory depression, and thereby estimate relative benefit versus risk," said Dr. Dahan. "In my previous work using this framework, OLINVYK demonstrated a greater clinical benefit compared to IV morphine across clinically relevant plasma concentrations. I am pleased to have this opportunity to build upon this work and study OLINVYK in a population of individuals highly relevant to its use in clinical practice."

    This is a Phase 1 randomized, double-blind, four-period crossover trial enrolling subjects ≥ 55 years old across a range of BMIs. The study aims to recruit ~50% of subjects who are ≥ 65 years old and ~30% of subjects with a BMI > 30 kg/m2. All subjects will receive two doses of OLINVYK and two doses of IV morphine to obtain a range of plasma concentrations that span the clinically relevant range for each medication. Respiratory depression will be assessed using the VRH measure, which is widely recognized as a precise method to assess respiratory physiology in humans. Analgesia will be measured using the cold pressor test, which is a valid and sensitive index of the pharmacologic effects of opioid agonists. The study will evaluate the ventilatory and analgesic effects of both treatments through population PK / PD modeling and clinical utility function analysis. Enrollment is expected to begin in Q3 2021, and the Company expects to report topline data by year-end 2021.

    "I am pleased to be partnering again with Dr. Dahan as we continue to advance our post-approval clinical development plan for OLINVYK," said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. "Our goal is to continue strengthening the body of evidence underlying the differentiated clinical profile of OLINVYK, and we believe the physiologic data that will be generated by this innovative study will help to further elucidate OLINVYK's therapeutic potential in the treatment of acute pain."

    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 doses greater than 3 mg should not be administered. 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 innovative 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's novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic pain and epilepsy, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.

    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

    PR & Media Contact:

    Sasha Bennett

    Director

    Clyde Group



    (239) 248-3409



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