Sprout Pharmaceutical’s female Viagra, Addyi, gets FDA approval

The US Food and Drug Administration, or FDA, approved on Tuesday Sprout Pharmaceutical’s Addyi, the first female libido pill. The drug is also known as the female Viagra.

However, The New York Times reports that the drug treats flagging or absent libido for both women and men. Existing drugs for men, such as Viagra, help men with erectile dysfunction get an erection or to treat testosterone deficiency, not to boost sexual desire.

Securing FDA approval is a victory for lobby groups such as Even the Score which said the drug was long overdue since men had their Viagra for about 17 years now. National Consumer League Executive Director Sally Greenberg calls Addyi the biggest breakthrough for women’s sexual health since the pill.

However, critics insist that the campaigns pressured the FDA into approving the drug despite known side effects such as low blood pressure, fainting, nausea, dizziness and sleepiness. In June, a panel of outside experts recommended through an 18-6 vote to approve flibanserin, the generic name of Addyi, with precautions. Flibanserin was studied in more than 11,000 women, according to a Sprout press release.

Reuters reports that the FDA approval comes with a strong warning. Addyi would only be available through certified health care professionals and pharmacies. It must be taken daily, unlike Viagra which is taken only hours before sex.

According to a survey, about 10 percent of women suffer from hypoactive sexual desire disorder which Addyi would treat. The availability of a drug to treat the disorder would likely change conversations in medical clinics similar to the way it became acceptable for men to talk about their inability to rise to the occasion when Viagra was approved by the FDA in 1998, said Dr Laurent Streicher, associate professor of clinical obstetrics and gynaecology at Northwestern University.

Sprout CEO Cindy Whitehead said that Addyi would be available beginning Oct 17. Since Sprout said it would not advertise the drug on radio or TV for 18 months, Whitehead said that the company plans to employ 200 medical reps to introduce the product to 30,000 doctors, mostly OBs and gynaecologists.

There is no exact price yet for Addyi, but Whitehead estimates it would cost about the same as erectile dysfunction pills on a monthly basis which is about $400 for 10 pills. She adds that the pill would likely be covered by insurance companies but with a co-payment of $30 to $75 a month.

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