"Female Viagra" Approved by FDA

The FDA has approved flibanserin (Addyi), the first drug to treat generalized hypoactive sexual desire disorder in premenopausal women.

The FDA has approved flibanserin (Addyi), the first drug to treat generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

Patients with HSDD have low sexual desire, which may cause personal distress or distress with partners. The condition is recognized among those who previously had no problems with sexual desire.

The pink pill manufactured by Sprout Pharmaceuticals has been described as the female equivalent to erectile dysfunction drug, sildenafil (Viagra).

Addyi is contraindicated in patients with liver impairment and those on moderate or strong CYP3A4 inhibitors, and the treatment carries a Boxed Warning about the risks of severe hypotension and loss of consciousness among those who drink alcohol.

Because of this, Addyi will only be available via certified health care professionals and certified pharmacies, according to an FDA press release.

“Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi,” the FDA press release stated.

Addyi was approved with a risk evaluation and mitigation strategy (REMS) because of the risk of severe hypotension and loss of consciousness. Prescribers of Addyi must be certified with the REMS program and complete training. They must also use a Patient-Provider Agreement form to emphasize the risks of drinking while taking Addyi.

Pharmacies must only provide Addyi if the patient has a prescription form from a certified prescriber, and pharmacists are responsible for also counseling patients prior to dispensing about the importance of alcohol abstinence.

Other adverse effects may include dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth.

The treatment, a serotonin 1A receptor agonist and serotonin 2A receptor antagonist, is taken once daily around bedtime to help decrease the risk of adverse effects. If women do not see results in 8 weeks, they should discontinue treatment.

Around 2400 premenopausal women with generalized HSDD took 100 mg of Addyi in 3 24-week placebo-controlled trials.

The participants had an average duration of HSDD of around 5 years, and the average age was 36 years.

The women tracked how many “satisfying sexual events” and how much sexual desire they experienced in the preceding 4 weeks and also reported their distress level related to low sexual desire. Addyi led to an increased number of satisfying sexual events on average by 0.5 to 1 additional event per month compared with placebo, according to an FDA press release. Sexual desire scores increased by 0.3 to 0.4 compared with placebo, and distress scores decreased by 0.3 to 0.4.

Around 10% of the women in the 3 trials who took the intervention treatment reported meaningful improvements in sexual events, desire, or distress.

The treatment has not been shown to enhance sexual performance.

FDA panels rejected new drug applications for Addyi in 2013 and 2014, but a panel delivered a favorable opinion on June 4, 2015, after Sprout Pharmaceuticals provided more data.

“[This] approval provides women distressed by their low sexual desire with an approved treatment option,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”