Business Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Speciality Dialogues
    • Education Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Business Medical Dialogues
    • News
        • Financial Results
        • Hospitals & Diagnostics
        • IT / Health Venture
        • Implants / Devices
        • Insurance
        • Key Movement
        • Pharmaceuticals
        • Policy
        • Technology
        • pharma-news
    • blog
    LoginRegister
    Business Medical Dialogues
    LoginRegister
    • Home
    • News
      • Financial Results
      • Hospitals & Diagnostics
      • IT / Health Venture
      • Implants / Devices
      • Insurance
      • Key Movement
      • Pharmaceuticals
      • Policy
      • Technology
      • pharma-news
    • blog
    • Home
    • Latest News
    • Alkermes' depression...

    Alkermes' depression treatment fails to get FDA panel backing

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2018-11-04T09:00:33+05:30  |  Updated On 4 Nov 2018 9:00 AM IST
    Alkermes depression treatment fails to get FDA panel backing




    New Delhi: An advisory panel to the U.S. Food and Drug Administration has recently voted against approving Alkermes Plc's treatment for depression in patients with an inadequate response to standard antidepressant therapies.

    The decision comes two days after FDA staff reviewers flagged abuse potential for the opioid-based depression treatment and raised questions on its efficacy.

    "I don't feel the evidence that was presented was substantial to show that there was efficacy ... I'm not convinced there is a big enough treatment effect to make a clinical difference," said Terri Warholak, a panel member.

    The panel voted 21-2 against the drug, ALKS 5461, a once-daily pill combining samidorphan and buprenorphine developed as an add-on treatment for major depressive disorder (MDD), saying the data did not support a favourable benefit-risk profile.

    ALKS 5461 is designed to rebalance brain function that becomes dysregulated in the state of depression and was seen as a driver of future revenue for the Dublin-based drugmaker.

    FDA staffers in the review on Tuesday also questioned the non-availability of trial data on the effects of the treatment on unborn infants when the treatment was administered to pregnant women.

    "We don't know what the mechanism of action is ... and the likelihood of dependence and withdrawal," said Jane Acri, also a panel member.

    "I think it's a very vulnerable population at risk for drug dependence in the first place."

    The FDA, which is slated to announce its final decision on Alkermes' drug by Jan. 31, 2019, is not mandated to follow the recommendation of the panel, but generally does.

    MDD affects about 16.2 million people in the United States, of which nearly two-thirds do not respond to currently approved therapies, highlighting the need for new therapies with novel mechanisms of action to treat the disorder.

    To date, only three antipsychotic drugs have been approved as add-on treatments for MDD. Alkermes' treatment would be the first opioid-based product for depression if approved.

    There are currently very few treatments for depression.






    Alkermesantidepressant therapiesdepressionFDAmajor depressive disorderMDDopioid-based productU.S. Food and Drug Administration

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      Popular Stories

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 13 Oct 2022 5:14 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok