A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder.

Trial Profile

A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder.

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2015

At a glance

  • Drugs Flibanserin (Primary)
  • Indications Decreased libido
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms MAGNOLIA; ORCHID
  • Sponsors Sprout Pharmaceuticals
  • Most Recent Events

    • 18 Aug 2015 According to a Sprout Pharmaceuticals media release, the US FDA has approved flibanserin 100 mg (Addyi) for the treatment of acquired generalized hypoactive sexual desire disorder in premenopausal women.
    • 04 Jun 2015 According to a Sprout Pharmaceuticals media release, the FDA advisory committee has recommended for approval flibanserin (ADDYI) for the treatment of hypoactive sexual desire disorder in premenopausal women.
    • 11 Dec 2013 Sprout Pharmaceuticals announced in a media release that it had received and appealed the FDA's Complete Response Letter (CRL) for flibanserin for the treatment of HSDD; the CRL was in response to resubmission of data from the Bouquet trials and others.
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