Addyi has been nicknamed the “female Viagra” even though it does not work like Pfizer Inc’s blockbuster Viagra pill for men that in 1998 became the first sexual-health/fda-approves-says-no-female-viagra-n411711″ target=”_blank”>approved drug for erectile dysfunction.
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Women with low sex drive may be possible candidates for therapy of flibanserin, which will be marketed under the trade name Addyi, if they do not have other explanations for low libido and are wishing to regain sexual desire.
Many women – some studies estimate this number is as high as one-third of all adult women – suffer from a condition known as female hypoactive sexual desire disorder (HSDD).
But the FDA does warn against its side effects, including low blood pressure and fainting, which are greatly increased with alcohol intake. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment”.
Women who took the drug in trials reported no more than one additional “sexually satisfying event” per month than women who received a placebo.
The FDA had previously rejected the drug in 2013 for its modest effect, and then faced a backlash from some doctors and researchers who claimed the agency was being sexist.
Originally the drug was produced by German company Boehringer Ingelheim.
“Women’s sexuality is very complicated”. “We’re concerned that drug companies are trying to sell hope and hype”, Breast Cancer Member Karuna Jaggar said. Panelists expressed concerns about potential side effects such as low blood pressure, fatigue and fainting, and questioned data on how the drug may interact with alcohol or birth control pills. She argues against suggestions the women’s movement was co-opted into pressuring the FDA to approve the drug.
The Food and Drug Administration officially approved a drug called flibanserin designed to treat women with hypoactive sexual desire disorder. The FDA is requiring REMS because of the increased risk due to the interaction between Addyi and alcohol.
Sprout also plans to reduce patients’ out-of-pocket costs with a copay assistance program when the drug is launched.
“Addyi is a game changer, in my opinion, for women’s health”, Cindy Whitehead, Sprout’s CEO, said.
But safety restrictions on the daily pill mean it will probably never achieve the blockbuster sales of men’s impotence drugs like Viagra, which have generated billions of dollars. Following the panel’s recommendations, the FDA gave its green signal to Addyi today (August 18, 2015). The essential feature of HSDD in women is a lack of desire for sex that causes distress.
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“Until now, physicians have been limited to recommending education, counseling, psychotherapy and, in some cases, off-label usage of testosterone and estrogen therapy as treatment options for otherwise healthy women with HSDD”, Zucconi said. Prior to Tuesday, there was no medication on the market to treat sexual disorder in premenopausal women.
