FDA approves first treatment for sexual desire disorder

WASHINGTON, D.C. -- The U.S. Food and Drug Administration approved on Tuesday Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women. Marketed by Raleigh-based Sprout Pharmaceuticals, Addyi (addy) has also come to be knows as "the little pink pill" or "female Viagara.

"HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” continued Dr. Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

Addyi can cause severely low blood pressure and loss of consciousness. These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines; pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.

In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.

The most common adverse reactions associated with the use of Addyi are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.