The Little Pink Pill: First FDA-Approved Treatment for Sexual Desire Disorder

By September 4, 2015Pharma Beat

On August 18, 2015, the FDA approved Addyi (flibanserin) once-daily for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD), the most common form of female sexual dysfunction in premenopausal women.

Although Addyi, manufactured by Sprout pharmaceuticals, has been frequently referred to as “female Viagra”, there are significant differences between the two drugs. Unlike Viagra which simulates blood flow to the genitals and is taken up to four hours before intercourse – Addyi targets receptors in the central nervous system and must be taken daily.

Although Addyi has generated considerable buzz in the media, controversy persists over the clinical efficacy and safety of the twice-rejected little pink pill. In clinical trials, treatment with Addyi increased the number of sexually satisfying sexual events by 0.5 to 1 additional event per month over placebo. Addyi carries a boxed warning; use of Addyi and alcohol increases the risk of severe hypotension and syncope. Due to safety issues associated with the drug, Addyi will only be available through certified and specialty trained health care professionals and pharmacies.

– Susan