Groundbreaking libido-boosting drug for women approved, but hold the champagne

For the first time ever, the FDA has approved a drug aimed at treating women who suffer from sexual desire disorders that can lead to significant distress and interpersonal problems. However, the FDA is warning that the drug, Addyi™ (flibanserin), which is approved for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, poses a serious risk of severe low blood pressure (hypotension) and loss of consciousness (syncope) when taken with alcohol and the agency is taking extra steps to ensure that prescribers and pharmacists warn patients of the risks of the potentially dangerous interactions.

HSDD

Addyi, which is manufactured by Sprout Pharmaceuticals, Inc., has been approved to treat acquired, generalized HSDD, which is a disorder that results in low sexual desire that causes “marked distress” or “interpersonal difficulty,” and that is not caused by a medical or psychiatric condition, relationship problems, or drug side effects. HSDD develops in patients who previously did not have problems with sexual desire and is considered to be generalized when it occurs regardless of the type of sexual activity, the partner, or the situation.

Female treatments

The FDA recognizes the challenges in developing treatments for female sexual dysfunction and emphasizes that it is continuing to encourage drug development in that area. The agency previously held a public meeting and workshop on female sexual dysfunction last year to consult with patients to discuss the challenges that sexual dysfunction poses to patients in their daily lives.

Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research (CDER), stated, “Today’s approval provides women distressed by their low sexual desire with an approved treatment option.” She further stated, “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.”

Alcohol interaction

Alcohol use is contraindicated while taking Addyi because it can interfere with the body’s breakdown of the drug, which can result in extreme hypotension and syncope. As a result of the potentially serious interactions with alcohol, the drug will be available only through certified health care professionals and certified pharmacies.

REMS

Due to the increased risk of severe hypotension and syncope, Addyi was approved with a risk evaluation and mitigation strategy (REMS), which requires prescribers to receive training by the REMS program and to counsel patients to avoid all alcohol during treatment. Pharmacies must also be trained and certified by the REMS program. The certified pharmacies can dispense Addyi only to patients who received a prescription from a certified prescriber and the pharmacists must counsel patients to avoid alcohol prior to dispensing the drug.

Boxed warning

Addyi was also approved with a Boxed Warning so as to highlight the risk of severe hypotension and syncope for patients who drink alcohol and who take certain medications or have liver impairments. The FDA is also requiring Sprout Pharmaceuticals to conduct three studies in women in order to better understand the risks of Addyi and alcohol interaction.