ATXI Avenue Therapeutics Inc.

10.44
+0.16  (+2%)
Previous Close 10.28
Open 10.54
52 Week Low 4.9625
52 Week High 11.83
Market Cap $174,168,463
Shares 16,682,803
Float 2,427,310
Enterprise Value $164,925,214
Volume 7,238
Av. Daily Volume 57,711
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Latest News

  1. NEW YORK, July 21, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced that the results from its Phase 3 study of IV tramadol in patients undergoing bunionectomy have been published in the peer-reviewed journal, Pain and Therapy.

    The objective of this Phase 3 study was to compare the analgesic benefit and tolerability of two doses of IV tramadol (50 mg and 25 mg) to placebo in adult patients undergoing bunionectomy, an orthopedic surgical model. Eligible patients were randomized (1:1:1 ratio) to IV tramadol 50 mg, 25 mg or placebo.  The primary endpoint was the summary of pain intensity differences ("SPID") over…

    NEW YORK, July 21, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced that the results from its Phase 3 study of IV tramadol in patients undergoing bunionectomy have been published in the peer-reviewed journal, Pain and Therapy.

    The objective of this Phase 3 study was to compare the analgesic benefit and tolerability of two doses of IV tramadol (50 mg and 25 mg) to placebo in adult patients undergoing bunionectomy, an orthopedic surgical model. Eligible patients were randomized (1:1:1 ratio) to IV tramadol 50 mg, 25 mg or placebo.  The primary endpoint was the summary of pain intensity differences ("SPID") over 48 hours.  Key secondary endpoints included SPID over 24 hours, total consumption of rescue analgesia, and patient global assessment of efficacy.  Safety assessments included treatment emergent adverse events ("TEAEs"), clinical laboratory tests, vital signs, and electrocardiograms ("ECG").  Assessment of the dose-response was an important objective of the study. The study established a clear dose response, with IV tramadol 50 mg demonstrating a statistically significant benefit (p < 0.05) over placebo for primary and all key secondary efficacy endpoints, whereas IV tramadol 25 mg demonstrated intermediate results between the 50 mg and placebo arms. IV tramadol 50 mg was well-tolerated.  The most common TEAEs were nausea and vomiting, and there were no meaningful differences among the treatments for vital signs, ECG, and laboratory assessments. The largest proportion of patients completed IV tramadol 50 mg (98.6%) compared to IV tramadol 25 mg (91.8%) and placebo (88.2%). The study concluded that IV tramadol 50 mg was effective and well-tolerated as a treatment for postoperative pain following bunionectomy surgery, while IV tramadol 25 mg, although well-tolerated, was judged to be an ineffective dose for the treatment of pain in this setting.

    Based on the results of the study, IV tramadol 50 mg was further developed in Avenue's Phase 3 program. The publication titled "Efficacy and Safety of Intravenously Administered Tramadol in Patients with Moderate to Severe Pain Following Bunionectomy:  A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study" can be accessed here.

    About Avenue Therapeutics

    Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ:FBIO). For more information, visit www.avenuetx.com.  

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the COVID-19 outbreak and its potential impact on our employees' and consultants' ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    Contacts:

    Jaclyn Jaffe and William Begien

    Avenue Therapeutics, Inc.

    (781) 652-4500

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  2. NEW YORK, June 05, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced the following publications in peer-reviewed journals.

    The publication titled "Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial" has been published in Drugs in R&D and can be accessed here.

    The objective of this Phase 3 study was to evaluate the safety, tolerability and efficacy of IV tramadol 50 mg versus placebo in patients following abdominoplasty surgery, a soft-tissue surgical model. The study included an active comparator arm…

    NEW YORK, June 05, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced the following publications in peer-reviewed journals.

    The publication titled "Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial" has been published in Drugs in R&D and can be accessed here.

    The objective of this Phase 3 study was to evaluate the safety, tolerability and efficacy of IV tramadol 50 mg versus placebo in patients following abdominoplasty surgery, a soft-tissue surgical model. The study included an active comparator arm, IV morphine 4mg. While the study was not powered to provide statistical comparison of the two active arms, its sample size allowed for assessment of the general comparability of the treatment regimens. The results of the study demonstrated that IV tramadol was statistically superior to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes. IV tramadol also demonstrated numerically lower rates of incidence of the most common treatment-emergent adverse events than IV morphine.

    The publication titled "IV Tramadol – A New Treatment Option for Management of Post-Operative Pain in the U.S.: An Open-Label, Single-Arm, Safety Trial Including Various Types of Surgery" has been published in Journal of Pain Research and can be accessed here.

    This safety study was a Phase 3, single-arm, open-label safety study performed in patients undergoing a variety of elective bone and soft tissue surgeries to evaluate the safety and tolerability of IV tramadol 50 mg. The study enrolled 251 patients with both orthopedic and soft tissue surgeries well represented. Dosing was completed in 95% of the patients. IV tramadol was well tolerated, and the adverse events were consistent with known tramadol pharmacology. At the end of treatment, approximately 95% of the patients reported that study medication was good, very good, or excellent for controlling pain.

    The publication titled "Misuse of Tramadol in the United States: An Analysis of the National Survey of Drug Use and Health 2002-2017" has been published in Substance Abuse: Research and Treatment and can be accessed here.

    The objective of the study was to analyze the rates of misuse – use in any way not directed by a doctor – of products containing oral tramadol, a Schedule IV opioid, as compared to comparator Schedule II opioids (morphine, oxycodone, and hydrocodone) and alprazolam, a commonly prescribed Schedule IV controlled substance in the U.S. from the National Survey of Drug Use and Health ("NSDUH").  NSDUH is an annual, congressionally mandated household survey of self-reported alcohol, drug and tobacco use among non-institutionalized persons (≥12 years old) in the U.S. The study showed a low prevalence of oral tramadol misuse as compared to other commonly prescribed opioids when adjusted for prescription volume. Estimates of reported oral tramadol misuse remained relatively stable over time. Reports of oral tramadol misuse were also much less than alprazolam, another Schedule IV drug.

    About Avenue Therapeutics

    Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ:FBIO). For more information, visit www.avenuetx.com.  

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the COVID-19 outbreak and its potential impact on our employees' and consultants' ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    Contacts:

    Jaclyn Jaffe and William Begien

    Avenue Therapeutics, Inc.

    (781) 652-4500

     

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  3. NEW YORK, May 29, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced that it will host the Company's 2020 Annual Meeting of Stockholders ("Annual Meeting") virtually due to public health concerns resulting from the coronavirus (COVID-19) outbreak, and government-recommended and required limits on public gatherings. Holding the Annual Meeting online will also protect the health and safety of the Company's stockholders, directors and employees.

    The Annual Meeting will begin at 10:00 a.m. Eastern Time on Tuesday, June 16, 2020, and will be conducted in a virtual format only. Stockholders will not be able to attend…

    NEW YORK, May 29, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced that it will host the Company's 2020 Annual Meeting of Stockholders ("Annual Meeting") virtually due to public health concerns resulting from the coronavirus (COVID-19) outbreak, and government-recommended and required limits on public gatherings. Holding the Annual Meeting online will also protect the health and safety of the Company's stockholders, directors and employees.

    The Annual Meeting will begin at 10:00 a.m. Eastern Time on Tuesday, June 16, 2020, and will be conducted in a virtual format only. Stockholders will not be able to attend the Annual Meeting in person; however, stockholders of record as of the close of business on April 20, 2020 will be able to vote through the online platform.

    Investors can access the virtual Annual Meeting and participate in the following ways:

    • Visit www.virtualshareholdermeeting.com/ATXI2020 and enter the 16-digit control number included on your Important Notice Regarding the Availability of Proxy Materials.
       
    • Log into the meeting platform beginning at 9:45 a.m. Eastern Time on June 16, 2020.
       
    • Vote during the Annual Meeting by following the instructions available on the meeting website during the Annual Meeting.

    A list of stockholders entitled to vote at the Annual Meeting will be available for examination for any purpose germane to the Annual Meeting for ten days prior to the Annual Meeting. You may email Avenue Therapeutics, Inc. at to coordinate arrangements to view the stockholder list. The stockholder list will also be available during the Annual Meeting at www.virtualshareholdermeeting.com/ATXI2020.

    If you encounter any technical difficulties with the virtual meeting platform on the meeting day, a phone number for technical support will be provided on the meeting page at www.virtualshareholdermeeting.com/ATXI2020. Technical support will be available beginning at 9:45 a.m. Eastern Time on June 16, 2020 and will remain available until the meeting has ended.

    Whether or not stockholders plan to attend the virtual Annual Meeting, Avenue urges stockholders to select one of the methods described in the proxy materials to vote and submit their proxies in advance of the Annual Meeting.

    About Avenue Therapeutics
    Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ:FBIO). For more information, visit www.avenuetx.com.  

    Forward-Looking Statements
    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the COVID-19 outbreak and its potential impact on our employees' and consultants' ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    Contacts:
    Jaclyn Jaffe and William Begien
    Avenue Therapeutics, Inc.
    (781) 652-4500

     

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  4. NEW YORK, May 11, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2020.

    "In the first quarter of 2020, the U.S. Food and Drug Administration ("FDA") accepted our IV tramadol New Drug Application ("NDA") submission for review and set a Prescription Drug User Fee Act ("PDUFA") goal action date of October 10, 2020," stated Lucy Lu, M.D., Avenue's President and CEO. "2020 is gearing up to be an exciting year for Avenue as we anticipate that the merger with InvaGen Pharmaceuticals Inc., a subsidiary of Cipla Limited, will be completed…

    NEW YORK, May 11, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2020.

    "In the first quarter of 2020, the U.S. Food and Drug Administration ("FDA") accepted our IV tramadol New Drug Application ("NDA") submission for review and set a Prescription Drug User Fee Act ("PDUFA") goal action date of October 10, 2020," stated Lucy Lu, M.D., Avenue's President and CEO. "2020 is gearing up to be an exciting year for Avenue as we anticipate that the merger with InvaGen Pharmaceuticals Inc., a subsidiary of Cipla Limited, will be completed shortly after the PDUFA date, pending a positive outcome and other certain conditions being satisfied."

    Recent Corporate Highlights:

    • In February 2020, the FDA accepted Avenue's IV tramadol NDA for review with a PDUFA goal action date of October 10, 2020.
    • In April 2020, we announced that two e-posters highlighting efficacy and safety results from our Phase 3 program are available for online viewing from the cancelled Annual Regional Anesthesiology and Acute Pain Medicine Meeting hosted by the American Society of Regional Anesthesia and Pain Medicine ("ASRA").
      • The e-poster (816) titled "Intravenous Tramadol is Effective in Management of Postoperative Pain Following Abdominoplasty: A 3-arm Randomized Controlled Trial" presents data from the Phase 3 abdominoplasty study and can be found here.
      • The e-poster (1001) titled "IV tramadol – A New Treatment Option for Management of Post-Operative Pain: A Safety Trial Including Various Types of Surgery" presents data from the Phase 3 safety study and can be found here.

    2020 Financial Results:

    • Cash Position: As of March 31, 2020, our cash and cash equivalents totaled $6.6 million, compared to $8.7 million at December 31, 2019, a decrease of $2.1 million.  
    • R&D Expenses: Research and development expenses for the first quarter of 2020 were $0.7 million, compared to $10.2 million in the first quarter of 2019. This decrease of $9.5 million was primarily attributable to the completion of our abdominoplasty and safety studies in 2019.
    • G&A Expenses: General and administrative expenses for the first quarter of 2020 were $0.6 million, compared to $1.1 million in the first quarter of 2019. This decrease of $0.5 million was primarily attributable to decreases in non-cash stock compensation expenses and professional fees.
    • Net Loss: Net loss attributable to common stockholders for the first quarter of 2020 was $1.2 million, or $0.08 per share, compared to a net loss of $11.3 million, or $0.82 per share, in the first quarter of 2019.             

    About Avenue Therapeutics
    Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ:FBIO). For more information, visit www.avenuetx.com.  

    Forward-Looking Statements
    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the COVID-19 outbreak and its potential impact on our employees' and consultants' ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    Contacts:
    Jaclyn Jaffe and William Begien
    Avenue Therapeutics, Inc.
    (781) 652-4500


    AVENUE THERAPEUTICS, INC.
    Condensed Balance Sheets
    ($ in thousands, except for share and per share amounts)

           
      March 31,   December 31,
        2020       2019  
      (unaudited)    
           
    ASSETS      
    Current Assets:      
    Cash and cash equivalents $ 6,574     $ 8,745  
    Prepaid expenses and other current assets   122       170  
    Total Assets $ 6,696     $ 8,915  
           
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Current Liabilities:      
    Accounts payable and accrued expenses $ 790     $ 1,101  
    Accounts payable and accrued expenses - related party   133       14  
    Licenses payable   -       1,000  
    Total current liabilities   923       2,115  
           
    Total Liabilities   923       2,115  
           
    Commitments and Contingencies      
           
    Stockholders' Equity      
    Preferred Stock ($0.0001 par value), 2,000,000 shares authorized      
    Class A Preferred Stock, 250,000 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively   -       -  
    Common Stock ($0.0001 par value), 50,000,000 shares authorized      
    Common shares, 16,682,803 and 16,682,190 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively   2       2  
    Additional paid-in capital   75,130       74,915  
    Accumulated deficit   (69,359 )     (68,117 )
    Total Stockholders' Equity   5,773       6,800  
    Total Liabilities and Stockholders' Equity $ 6,696     $ 8,915  
           

    AVENUE THERAPEUTICS, INC.
    Condensed Statements of Operations
    ($ in thousands, except for share and per share amounts)
    (Unaudited)

      For the Three Months Ended
      March 31,   March 31,
        2020       2019  
    Operating expenses:      
    Research and development $ 697     $ 10,241  
    General and administrative   577       1,119  
    Loss from operations   (1,274 )     (11,360 )
           
    Interest income   (32 )     (91 )
    Net Loss $ (1,242 )   $ (11,269 )
           
    Net loss per common share outstanding, basic and diluted $ (0.08 )   $ (0.82 )
           
    Weighted average number of common shares outstanding, basic and diluted   16,474,655       13,742,649  
           

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  5. NEW YORK, April 23, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced that two e-posters highlighting efficacy and safety results from its Phase 3 program are available for online viewing from the cancelled Annual Regional Anesthesiology and Acute Pain Medicine Meeting hosted by the American Society of Regional Anesthesia and Pain Medicine ("ASRA"). The meeting was originally scheduled to take place April 23-25, 2020 in San Francisco, CA and was cancelled due to COVID-19 concerns.

    The e-poster (816) titled "Intravenous Tramadol is Effective in Management of Postoperative Pain Following Abdominoplasty: A 3-arm…

    NEW YORK, April 23, 2020 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) ("Avenue"), a company focused on the development of intravenous ("IV") tramadol for the U.S. market, today announced that two e-posters highlighting efficacy and safety results from its Phase 3 program are available for online viewing from the cancelled Annual Regional Anesthesiology and Acute Pain Medicine Meeting hosted by the American Society of Regional Anesthesia and Pain Medicine ("ASRA"). The meeting was originally scheduled to take place April 23-25, 2020 in San Francisco, CA and was cancelled due to COVID-19 concerns.

    The e-poster (816) titled "Intravenous Tramadol is Effective in Management of Postoperative Pain Following Abdominoplasty: A 3-arm Randomized Controlled Trial" presents data from the Phase 3 abdominoplasty study and can be found here.

    This Phase 3, multicenter, double-blind, placebo and active controlled trial evaluated the efficacy and safety of IV tramadol in 370 patients following abdominoplasty surgery. Patients were randomized to a postoperative regimen of IV tramadol 50 mg, placebo or IV morphine 4 mg. The primary endpoint of the study assessed the analgesic efficacy of IV tramadol compared to placebo as measured by SPID24 (sum of pain intensity differences through 24 hours post first dose). The key secondary endpoints included SPID48 (sum of pain intensity differences through 48 hours post first dose), total consumption of rescue medicine and Patient Global Assessment. IV tramadol 50 mg was statistically significantly superior to placebo for the primary efficacy endpoint and all three key secondary efficacy endpoints. In addition, IV tramadol demonstrated a similar efficacy profile to that of IV morphine 4 mg, a standard-of-care active comparator in this study. Topline results from this study were announced in June 2019.

    The e-poster (1001) titled "IV tramadol – A New Treatment Option for Management of Post-Operative Pain: A Safety Trial Including Various Types of Surgery", presents data from the Phase 3 safety study and can be found here.

    The Phase 3 safety study was a single-arm open label study that enrolled patients undergoing a range of surgical procedures including both orthopedic and soft tissue surgeries. IV tramadol 50 mg was administered at Hours 0, 2, 4, and every 4 hours thereafter for up to 7 days of treatment. Patients were allowed to use non-opioid medications per treating physicians' discretion if additional pain relief was needed. While efficacy was not a primary objective of the study, patient satisfaction with treatment was measured with Patient Global Assessment.

    IV tramadol 50 mg was well tolerated in this real-world trial, with only 4% of patients discontinuing for adverse events. The most commonly observed adverse events were nausea and vomiting, which is consistent with known tramadol pharmacology. At the end of treatment, 95% of patients reported that study medication was good, very good, or excellent for controlling pain. No patients discontinued the study due to a lack of efficacy.

    "The results of these two studies indicate that IV tramadol may become a useful option in patients where exposure to conventional opioids is not desired," said Harold Minkowitz, M.D., an anesthesiologist at Memorial Hermann Memorial City Medical Center in Houston, TX. "IV tramadol, with its dual mechanisms of action, may fill a gap between IV non-opioid medicine and conventional opioids. The availability of IV tramadol as an alternative to conventional opioid analgesics should be a valuable option for U.S. clinicians who treat pain in the hospital setting."

    About Avenue Therapeutics
    Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ:FBIO). For more information, visit www.avenuetx.com.  

    Forward-Looking Statements
    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the COVID-19 outbreak and its potential impact on our employees' and consultants' ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    Contacts:
    Jaclyn Jaffe and William Begien
    Avenue Therapeutics, Inc.
    (781) 652-4500

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