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.