After a long and controversial process, the US Food and Drug Administration (FDA) has approved the first-ever drug aimed at boosting female libido.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
Flibanserin (Addyi) — also known as “Female Viagra” or “Pink Viagra” — will be marketed by Sprout Pharmaceuticals. It is approved to treat premenopausal women. The nonhormonal therapy — a 5-hydroxytryptophan (HT)(1A) receptor agonist and 5-HT(2A) receptor antagonist — was approved for hypoactive sexual desire disorder (HSDD). The HSDD diagnosis appeared in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-4), but was subsumed into a larger category of Female Sexual Interest/Arousal Disorder in the latest edition, DSM-5.
The once-daily 100-milligram tablet is to be taken at bedtime, and alcohol use will be contraindicated due to common side effects including drowsiness and dizziness. The label will include a boxed warning about the potential for increased hypotension or syncope with alcohol. The FDA is requiring Sprout to conduct three postmarketing studies in patients to better understand the interaction between flibanserin and alcohol. Concomitant use with moderate-to-strong CYP3A4 inhibitors — such as antifungals — will also be contraindicated and included in the boxed warning.
“HSDD is a very real problem for women,” Leah Millheiser, MD, director of the female sexual medical program at Stanford University School of Medicine, told Medscape Medical News. Dr Millheiser said that the condition is caused by an imbalance in neurotransmitters, and that “there is absolutely a need for a drug that’s been shown to be safe and effective.”