Home > Online Clinic News > Flibanserin Submitted to the FDA Again

Latest News

by Robert MacKay, Friday, June 28, 2013 | Categories: Flibanserin

Sprout Pharmaceuticals has successfully sent Flibanserin to be reviewed by the Food and Drug Administration (FDA). The drug would be for women suffering from Hypo-Active Sexual Desire Disorder (HSDD).

This disorder, according to an academic article in the Journal of Sexual Medicine, might affect about 10% of premenopausal women. HSDD is described as a persistent lack of sexual desire or thoughts, which becomes a concern and may affect interpersonal relationships.

A recent clinical trial reported significant results. Participating premenopausal women suffering from HSDD were randomised and then had to take either flibanserin or a placebo pill once a day at bedtime for 24 weeks. The women taking flibanserin reported, at the end of the trial, a higher number of satisfying sexual events and lower level of distress compared to women taking the placebo pill. Side effects included nausea, dizziness and sleepiness.

This submission of the drug for review is a response to the growing concern about women’s sexual dysfunctions addressed in the Prescription Drug User Fee Act (PDUFA) V of 2012. The results of this trial are very interesting, and the FDA is expected to review the drug at some point before the end of the year. You can read more about the study at this online library.

We know that many observers of medical innovations are highly sceptical about the existence of HSDD but we can tell them from clinical practice that it is very real for some women and it has destroyed relationships. This is why this area of medicine is one of 20 highlighted as a priority for new product innovations.





Free Online Assessment
Quick and Without Obligation
 
We use cookies on this website. By using this site, you agree that we may store and access cookies on your device. Find out more Close