(RxWiki News) The first-ever treatment for a sexual desire disorder just got a nod of approval from the US Food and Drug Administration (FDA) — but it came with a warning.
On Tuesday, the FDA approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The agency did, however, send the drug forward with a black box warning.
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
The black box warning notes that HSDD patients taking Addyi could experience dangerously low blood pressure or loss of consciousness — particularly if they drink alcohol.
HSDD is a disorder marked by low sex drive. HSDD patients often feel stress or anxiety surrounding their lack of sexual desire.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Dr. Woodcock said. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
Addyi's approval does mark a first in the pharmaceutical industry. Before the new drug's approval, the FDA had not approved any medications — for women or men — that treated sexual desire disorders.
According to the FDA, it's not yet clear how the Sprout Pharmaceuticals drug boosts sex drive in premenopausal women. However, the once-daily medication did appear to work in three large studies of premenopausal HSDD patients. Compared to a fake treatment (placebo), Addyi was tied to 0.5 more satisfying sexual events per month on average.
Furthermore, patients taking Addyi said they felt less anxiety and stress tied to their HSDD.
The most common side effects these patients reported were tiredness, dizziness, fatigue, nausea, dry mouth and insomnia.