FDA Unsure About Sprout’s Female Sexual Dysfunction Drug

The FDA is still not convinced that Sprout Pharmaceutical’s libido-enhancing drug for women is safe, particularly when mixed with alcohol, and has asked two of its advisory committees to consider whether alcohol should be contraindicated in the product’s labeling.

In briefing materials released ahead of an advisory committee meeting, the agency says Addyi (filbanserin) can cause blood pressure to drop, putting women at risk of fainting and injuring themselves.

While studies confirmed that the drug leads to more satisfying sexual events, the improvement was numerically small, leading the FDA to question whether the benefit outweighs the risks.

Last week, the Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will meet jointly to consider whether the data support approving Addyi for the proposed indication.

Among other concerns, the FDA notes that Sprout’s alcohol interaction study was conducted mainly in men who were moderate drinkers and may not adequately assess the risk in premenopausal women and women who consume less alcohol than moderate drinkers. The agency wonders whether it’s unrealistic to expect women taking Addyi to avoid alcohol indefinitely.

The FDA also wants to know whether a risk evaluation and mitigation strategy is necessary and whether Sprout’s proposed REMS, which consists of a medication guide and communication plan, is sufficient to ensure Addyi’s safe use.

The FDA first rejected filbanserin in 2010 after an advisory panel said the benefits didn’t outweigh the risks. Boehringer-Ingelheim, which developed the drug, then sold it to Sprout, which resubmitted the NDA after running more trials. In 2013, the FDA said no a second time.

Raleigh, N.C.–based Sprout did not return a request for comment by press time.

Read the FDA’s briefing materials at www.fdanews.com/06-02-15-thursdaymeetingmaterials.pdf. — Lena Freund