FDA Defends Its Approval of Addyi for Women Despite Peculiar Circumstances | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Was the Food and Drug Administration (FDA) approval of flibanserin (Addyi) for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women long overdue? Or was it an error? In the face of divergent views, we at the FDA think it's important to clarify why flibanserin was approved after being rejected twice.

In the alcohol-interaction study, some participants had hypotension or syncope requiring intervention, such as being placed supine or in Trendelenburg position, when they took flibanserin with the equivalent of as little as two alcoholic drinks for someone weighing 70 kg (e.g., two 5-oz glasses of wine containing 12% alcohol). These participants had systolic and diastolic blood-pressure reductions of 28 to 54 mm Hg and 24 to 46 mm Hg, respectively. The study did not definitively delineate the risk in premenopausal women who take flibanserin at bedtime because 23 of the 25 participants were men.

Assuming that the effects of the alcohol interaction in women are at least as severe as those observed in men, the FDA required a boxed warning and an alcohol contraindication.