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
    • Repros to drop...

    Repros to drop testosterone drug in US if key study fails

    Written by savita thakur thakur Published On 2016-04-16T14:16:31+05:30  |  Updated On 16 April 2016 2:16 PM IST
    Repros to drop testosterone drug in US if key study fails

    Amrutha Penumudi : Repros Therapeutics Inc will abandon efforts to seek approval for its testosterone drug in the United States if an ongoing study fails, and shift focus to its uterine fibroids drug that showed promise in a mid-stage trial.


    Repros said on Tuesday its uterine fibroids drug Proellex stopped severe menstrual bleeding in 52 percent of women enrolled in the trial, pushing the company's shares up 175 percent the next day.


    The shares continued their climb on Thursday, hitting their highest in five and a half months.


    The results offered some hope to the tiny drug developer, whose testosterone drug Androxal was rejected by the U.S. Food and Drug Administration in December, sending its shares into a spiral over the next few months.


    Repros is conducting an additional study in response to the FDA's request for more data on Androxal, a drug that aims to treat secondary hypogonadism, a condition that leads to low testosterone levels in men, in combination with diet and exercise.


    "We'll know before the beginning of June whether there's a benefit; if not I'm not going to pursue it and we're going to focus all our efforts on Proellex," Chief Executive Joseph Podolski told Reuters.


    "That said, I am willing to bet that Androxal is going to show results," he said.


    Repros applied for U.S. marketing approval for Androxal in February 2015, based on data from four studies, two of which compared the drug to a leading FDA-approved treatment.


    The FDA rejected the application, saying the design of the studies was not adequate to demonstrate clinical benefit.


    The health regulator tightened its rules on the use of testosterone drugs last year, saying they should be reserved for patients with specific conditions, such as genetic disorders or tumors that impair the function of the testicles.


    There is still hope for Androxal in Europe, where regulators had a more positive outlook on it.


    With Androxal's future in doubt, the focus has shifted to Proellex, which has shown encouraging results in uterine fibroids and endometriosis, a disease in which tissue that normally grows inside the uterus grows outside it.


    The standards of care for uterine fibroids and endometriosis consist of surgery or short-term treatment with hormonal drugs, which cause loss in bone density. They are not recommended for use for more than six months.


    Laidlaw & Co analyst Yale Jen said the potential sales for the two indications combined could exceed $1 billion. (Reporting by Amrutha Penumudi in Bengaluru; Editing by Sayantani Ghosh and Don Sebastian)

    Amrutha PenumudiDon SebastianJoseph PodolskiReprosSayantani Ghoshtestosterone drugUS Food and Drug AdministrationUSFDA
    Source : Reuters

    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

    savita thakur thakur
    savita thakur thakur
      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