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A clinical study to assess the effect of the approved dose of Flibanserin (Addyi), co-administered with varying doses of alcohol on dizziness, syncope, and hypotension

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A clinical study to assess the effect of the approved dose of Flibanserin (Addyi), co-administered with varying doses of alcohol on dizziness, syncope, and hypotension

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Apr 2019

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At a glance

  • Drugs Flibanserin (Primary)
  • Indications Female sexual dysfunction
  • Focus Adverse reactions; Therapeutic Use

    • Most Recent Events

    • 12 Apr 2019 According to a Sprout Pharmaceuticals media release, the company received the FDA ordered Addyi labeling change to lessen the alcohol restriction on April 11, 2019.
    • 12 Apr 2019 According to a Sprout Pharmaceuticals media release, the company announced that FDA existing warnings and restrictions regarding alcohol use in women taking Addyi (flibanserin) for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) are overly restrictive and overstate the risk of alcohol interaction. This decision was based on 3 studies (CTP 305748, 305753 and 305755).
    • 28 Mar 2019 New trial record

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