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news.Sprout Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Addyi (flibanserin 100mg), a non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
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HSDD is a constant absence of sexual thoughts, fantasies, responsiveness and willingness to participate in sexual activity.
Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, which is taken once daily at bedtime.
The drug is claimed to be the first and only FDA-approved treatment for this sexual dysfunction, which affects up to one in ten women in the US.
Sprout CEO Cindy Whitehead said: "It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition.
"We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence."
The approval is based on three North American, Phase III, 24-week, randomized double blind, placebo-controlled, studies of premenopausal women with HSDD.
The studies revealed that the medicine provides improvements in desire for sex and reduce distress from the loss of sexual desire.
The most common adverse reactions associated with the use of Addyi are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.
In October 2010, Boehringer Ingelheim stopped development of the drug after FDA’s negative evaluation. The drug’s development process rights were later acquired by Sprout.
Image: Hypoactive sexual desire disorder (HSDD) affects one in ten women in the US. Photo: courtesy of anankkml / FreeDigitalPhotos.net.