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Addyi Approval Status

  • FDA approved: No
  • Brand name: Addyi
  • Generic name: flibanserin
  • Company: Sprout Pharmaceuticals, Inc.
  • Treatment for: Hypoactive Sexual Desire Disorder

Addyi (flibanserin) is a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) in development for the treatment of hypoactive sexual desire disorder in premenopausal women.

On June 4, 2015, an FDA Advisory Committee recommended for approval Sprout Pharmaceutical’s flibanserin (Addyi) by an 18 to 6 vote for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. Flibanserin has been dubbed the “Female Viagra” and “the little pink pill”; however compared to Viagra, flibanserin has a distinctly different mechanism. As noted in FDA briefing documents, Addyi is a post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist and has action in the central nervous system. Addyi affects three brain neurotransmitters: increasing dopamine and norepinephrine (both responsible for sexual excitement) while decreasing serotonin (responsible for sexual satiety/inhibition). In 24-week Phase 3, placebo-controlled studies of premenopausal women, flibanserin demonstrated a significant increase in sexual desire, decrease in distress from the loss of sexual desire and an increase in the frequency of satisfying sex. Safety data showed the most common side effects were dizziness, nausea and sleepiness. An accompanying risk management program, such as a REMS, may be required prior to Addyi marketing, if approved.

FDA Approval Status for Addyi

DateArticle
Jun  4, 2015FDA Advisory Committee Recommends Approval for Addyi (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women
Feb 17, 2015Sprout Pharmaceuticals Resubmits Flibanserin NDA for Hypoactive Sexual Desire Disorder In Premenopausal Women
Feb 11, 2014Sprout Pharmaceuticals Receives Clear Guidance from FDA on Path Forward to Resubmit NDA for Flibanserin
Dec 11, 2013Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women
Oct  8, 2010Following Regulatory Feedback Boehringer Ingelheim Decides to Discontinue Flibanserin Development
May 19, 2010Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder

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