On August 18th, the U.S. Food and Drug Administration approved flibanserin, a drug designed to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
The drug’s manufacturer, Sprout Pharmaceuticals, plans to market the drug under the brand name Addyi. The company expects the drug to be available on October 17th.
Thought to affect one in ten women, HSDD is a chronic lack of sexual interest or desire. Women with HSDD do not have sexual fantasies and have no inclination toward sex with their partner. The situation cannot be explained by any other health condition, drug, or substance. It causes great distress for women and may lead to relationship difficulties.
A woman who has had healthy sexual desire in the past – but no longer does – is said to have acquired HSDD. Generalized HSDD occurs with any activity and any partner.
The drug is the first FDA-approved treatment for HSDD.
Flibanserin is meant to be taken once a day at bedtime. It works by raising levels of the neurotransmitters dopamine and norepinephrine, both of which promote sexual excitement. The drug also lowers levels of serotonin, a neurotransmitter that can suppress sexual desire.
Flibanserin has been controversial. Some supporters of the drug pointed out the many FDA-approved treatments available for men’s sexual problems, while few were available for women. But other experts felt that the drug did not work well enough to warrant approval and had too many negative side effects.
The FDA had twice rejected approval because of concerns over effectiveness and safety. The drug can cause hypotension (severely low blood pressure) and syncope (loss of consciousness). Women taking Addyi should not drink alcohol.
The approval comes with a risk evaluation and mitigation strategy (REMS):
• Healthcare providers must be trained and certified to prescribe Addyi.
• Clinicians must counsel patients and make sure they are aware of the increased risk for hypotension and syncope. Patients must also know about the risks of using alcohol while taking Addyi.
• Pharmacies must also undergo a training and certification process to dispense Addyi.
• Pharmacies may only fill prescriptions written by certified doctors.
• Before dispensing, pharmacists must counsel patients not to drink alcohol while taking Addyi.
In addition, Addyi labels will include a Boxed Warning that highlight the risks of hypotension, syncope, and interactions with alcohol. Addyi is contraindicated for women with liver impairment and those taking CYP3A4 inhibitors.
Sprout Pharmaceuticals must also conduct three more studies to explore the interactions of Addyi and alcohol.
International Society for Sexual Medicine
“What is flibanserin and how does it work?”
“FDA Approves First Drug To Boost Women's Sexual Desire”
(August 18, 2015)
“Sprout Pharmaceuticals Receives FDA Approval of ADDYI™ (Flibanserin 100 MG)”
(Press release. August 18, 2015)
U.S. Food and Drug Administration
“FDA approves first treatment for sexual desire disorder”
(News release. August 18, 2015)