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FDA Approves Drug to Treat Low Sexual Desire in Women

Aug 19, 2015

FDA Approves Drug to Treat Low Sexual Desire in WomenWomen coping with hypoactive sexual desire disorder (HSDD) may soon have a medical treatment option. 
On August 18th, the U.S. Food and Drug Administration (FDA) approved flibanserin, a drug developed to treat HSDD in premenopausal women. 
Women with HSDD have a chronic, persistent lack of interest in sex – to the point that they feel personal distress. They don’t fantasize about sex and don’t feel desire for their partner. And no health condition, drug, or substance can explain its disappearance.
HSDD is troublesome for both partners and can lead to arguments, depression, and relationship issues. 
The FDA gave the green light to treat flibanserin for cases when HSDD is acquired and generalized. “Acquired” means that the woman has had a healthy sex drive in the past. She might have been full of desire for her partner before, but no longer feels it. “Generalized” means that this lack of desire happens with any partner and with any type sexual activity.
An estimated one in ten women are believed to have HSDD. But until now, there was no FDA-approved treatment. 
The drug, which will be marketed under the name Addyi, works by balancing chemicals in the brain. It increases the levels of two neurotransmitters – dopamine and norepinephrine – which are important for sexual excitement. It also decreases levels of serotonin, which can hinder sex drive. 
The road to flibanserin’s approval was rocky. It was twice rejected by the FDA because of safety concerns. Some experts felt that it wasn’t effective enough. 
Last October, the FDA held meetings and workshops so that patients and experts could share their views on HSDD and its treatment. In June, after considering new research, an FDA advisory panel recommended approval.
Still, Addyi can have some serious side effects. A woman’s blood pressure can drop substantially (hypotension). There is also a chance that she might lose consciousness (syncope). Women should also not drink alcohol while taking Addyi.
Sprout Pharmaceuticals, the maker of Addyi, expects the drug to be available by October 17, 2015. However, not all doctors will be able to prescribe it. The FDA’s approval has some strict requirements. 
Doctors must be specially trained and certified to prescribe Addyi. They must also counsel patients on the risks, especially those concerning blood pressure, loss of consciousness, and interactions with alcohol. 
Similarly, pharmacies must be trained and certified to dispense the drug and may only do so if a certified doctor prescribes it. Pharmacists must also make sure patients are aware of the risks. 
Addyi labels will include a “boxed warning” from the FDA that explains the risks. And Sprout Pharmaceuticals is required to conduct three more studies to investigate the interaction of Addyi and alcohol. 
International Society for Sexual Medicine
“What is flibanserin and how does it work?”
Stein, Rob
“FDA Approves First Drug To Boost Women's Sexual Desire”
(August 18, 2015)
Sprout Pharmaceuticals
“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)