Addyi, the "female Viagra," finally got the green light from the U.S. Food and Drug Administration, but not without warnings about potential side effects. The FDA approved the little pink pill Tuesday, giving a cause for celebration to those who have campaigned for its approval in spite of two previous rejections. Janet Woodcock, FDA's director for the Center for Drug Evaluation and Research, said the drug gives women with low sexual desire "an approved treatment option."
"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," Woodcock said in a press release.
Flibanserin, which will be commercially known as Addyi, is the first drug approved as treatment for lack or absence of libido, a condition called generalized hypoactive sexual desire disorder (HSDD). It is targeted specifically for premenopausal women. Before Addyi, no other drug has received FDA approval to treat sexual desire disorders in both men and women, the FDA said.
Unlike Viagra, which addresses erectile dysfunction and is taken before intercourse, Addyi is to be taken every night. That's because while the little blue pill treats a physical problem, the little pink pill deals with chemicals in the brain and acts more like an antidepressant.
Flibanserin was rejected twice before: once in 2010 while it was still under Boehringer when the FDA dismissed it as having the same effect as a placebo, and another time in 2013 under Sprout Pharmaceuticals when it was rejected on grounds of its adverse side effects outweighing its benefits.
"It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition," Sprout Pharmaceuticals chief executive officer Cindy Whitehead said in a press release. "We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence."
"This is the biggest breakthrough for women's sexual health since the pill," National Consumers League executive director Sally Greenberg said, according to The New York Times.
However, the FDA gives strong warnings about the side effects of Addyi, which can cause hypotension (or extremely low blood pressure) and loss of consciousness. These side effects are increased during alcohol intake because alcohol interferes with the drug's breakdown in the body. The FDA warns that "health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi."
"Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies," Woodcock said. "Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment."
The drug's other side effects include dizziness, nausea, fatigue, sleepiness, insomnia and dry mouth.
Addyi is expected to be available to consumers on Oct. 17.
