Sprout Pharmaceuticals can now begin producing the drug under the brand name Addyi.
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The recent approval appears to be influenced by the company’s argument that there are 26 FDA sexual-health/fda-approves-says-no-female-viagra-n411711″ target=”_blank”>approved drugs to treat various sexual dysfunctions for men but not a single one for women’s most common sexual complaint.
“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment”, Woodcock added.
The German company Boehringer Ingelheim initially developed flibanserin, the active drug in Addyi, as an anti-depressant but switched it to a sex drive treatment when patients in clinical trials began reporting improved sexual desire. Though it has caught the public’s attention as a “female Viagra” the controversial drug works differently than sildenafil (Viagra/Pfizer). That prompted the company to include a warning not to use alcohol with the drug, which must be taken daily. Viagra works by stimulating blood flow to the genitalia, and does not directly affect male libido.
For women whose low sexual desire isn’t the result of relationship problems, a history of abuse, depression, medical ailments, medication side effects or other non-biologic factors, flibanserin will help restore their sexual appetite.
Rebecca Zucconi, an assistant professor of medical sciences at the Frank H. Netter School of Medicine at Quinnipiac University, said the condition is the most commonly diagnosed sexual dysfunction in women.
Due to the potential side effects, the FDA has approved the drug with a couple of caveats.
The FDA notes that flibanserin (Addyi) can cause severe low blood pressure, as well as the loss of consciousness-risks that are exacerbated with alcohol or certain drugs that interfere with the way that flibanserin is broken down in the body.
No word yet from the Food and Drug Administration on the approval of a new medication for women to boost desire. “You have to take it for weeks and months in order to see any benefit at all”, said Leonore Tiefer, a psychologist and sex therapist who organized a petition last month calling on the FDA to reject the drug. Flibanserin will be available beginning October 17, Whitehead said. Because of the side effects, the FDA is requiring that doctors and pharmacists be specially certified to deal with the drug.
The rejection sparked a lobbying campaign by Sprout, aided by some women’s groups who accused the FDA of gender bias because it had approved Viagra for men – a charge the FDA vigorously rejected.
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“Addyi is a game changer, in my opinion, for women’s health”, Cynthia Whitehead, CEO of Sprout Pharmaceuticals, told NPR.
