Addyi 'Female Viagra' Gets FDA Approval, But With Warnings

The “female Viagra,” which will be commercially known as Addyi, was approved by the FDA and will be available on the market on October.

By Suzette Gutierrez | Aug 20, 2015 08:01 AM EDT

The side effects of Addyi include hypotension, loss of consciousness, dizziness, nausea, insomnia, sleepiness and fatigue. (Photo : Twitter Photo Section)

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.

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Addyi "Female Viagra" Gets FDA Approval, But With Warnings

FDA advisory panel backs 'female Viagra' to treat low sexual drive

Published time: June 05, 2015 03:52

Reuters / Srdjan Zivulovic

A Food and Drug Administration panel voted 18-6 to recommend approving Flibanserin, a drug to help women with low sexual desire. The FDA had rejected the drug twice before, saying the side effects outweighed its benefits.

Those side effects include sleepiness, a drop in blood pressure, and fainting. These effects are increased when the drug is combined with alcohol. On two previous occasions, the FDA had said the drug – often referred to as a “female Viagra” – had a “challenging benefit/risk assessment.”

The committee on Thursday described the drug’s benefit as “moderate” or “marginal.”

Flibanserin was first created to combat depression, which it wasn’t very good at doing. While being dubbed the “female Viagra,” it has little in common with the famous blue pill that sustains erections in men for several hours by increasing blood flow to the genitalia. Unlike Viagra, which is taken when desired, Flibanserin has to be taken every day whether a woman wants sex or not. It works on neurotransmitters in the brain, affecting receptors that react to chemicals such as serotonin and dopamine, thus increasing sexual desire in some women.

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The drug’s developer, Sprout Pharmaceuticals, conducted a series of double-blind trials lasting 24 weeks in which 40-60 percent of the women participating benefited from the treatment. The committee found that, after adjusting the data to account for the placebo effect, the drug wound up helping only about 10 percent, with frequency of sexual desire increasing from two to three times a month to four times a month.

The panel’s other concern was Flibanserin’s interaction with other drugs like birth control pills. Some members were worried about a two-year cancer study that found mice given four times the daily 100 milligram dose experienced an increased risk of developing breast cancer tumors. The Washington Post reported “one advisory panel called the potential link to cancer a ‘show stopper,’ especially as the double-blind trials only lasted from one year to 18 months.”

Sprout Pharmaceuticals enlisted a number of women’s groups in a campaign to promote the drug as a feminist issue, pointing out that men have drugs like Viagra, but that nothing similar exists for women.

One supporter of the drug is Sally Greenberg, executive director of the National Consumers League, who said loss of libido is very destructive to women’s relationships, their families, and their self-image.

“We know this is a problem with their brain chemistry. Just like depression. And, just like depression, their brain chemistry can be adjusted. We can treat it. And we should treat it,” Greenberg told The Washington Post.

“I think this is a huge moment for women’s sexual health, in the way that the pill was for women’s sexual health and ability to control their own destiny,” she said.

FDA advisory panel backs "female Viagra" to treat low sexual drive