Due to risks associated with drinking alcohol while taking the drug, the FDA
says flibanserin will only be available through specially certified health care professionals and certified pharmacies.
Not exact matches
Valeant Pharmaceuticals International Inc.
said on Thursday it would buy Sprout Pharmaceuticals, whose drug
flibanserin (Addyi) became the first approved treatment for low sexual desire in women, for about $ 1 billion with milestone payments.
Stahl
says that these same mechanisms probably elicit the side effects that concern potential users —
flibanserin's effect on a serotonin receptor called 5 - HT1A likely causes dizziness and nausea, and its effects on another, 5 - HT2A, are likely linked to sleepiness.
The findings «suggest that the benefits of
flibanserin are marginal,» given that «one in three women experience side effects, of which the most common ones include dizziness, sleepiness, nausea, and tiredness,»
said lead author Dr. Loes Jaspers, of Erasmus University Medical Center in Rotterdam, the Netherlands.
As the three clinical trials progressed over the course of about 8 years, so did techniques in determining desire,
says Kingsberg, a reproductive biology and psychology researcher at University Hospitals Case Medical Center in Cleveland, Ohio, and consultant to Sprout Pharmaceuticals, which bought
flibanserin from Boehringer Ingelheim in 2011, and was in turn purchased last week by Valeant Pharmaceuticals.
Jaspers
said their findings suggest the FDA should reconsider its approval of
flibanserin but cautioned that the agency may have taken other factors into account to make its decision.
«I believe if
flibanserin is going to play a role in sexual dysfunction for women, it's going to be part of a complex approach to addressing the women's sexual health issues,» Jayne
says.
says John Thorp, an obstetrician and gynecologist at the University of North Carolina, Chapel Hill, who led the DAISY clinical trial for
flibanserin, published in 2012 in the Journal of Sexual Medicine.