Clinching a victory for a lobbying campaign that accused the U.S. Food and Drug Administration of gender bias for ignoring the sexual needs of women, the first prescription drug to enhance the female sexual drive won regulatory approval on Tuesday.
Move over Viagra and make way for the first medication approved by FDA to boost a womans libido - Addyi - from Sprout Pharmaceuticals. Addyi is thought to work by changing the balance of certain brain neurotransmitters like dopamine and serotonin. Dr. Janet Woodcock, a senior FDA official, said the agency was “committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
Cindy Whitehead, chief executive of Sprout, said Addyi would be available starting October 17.
The FDA rejected Addyi twice - in 2010 and 2013 - citing marginal effectiveness and side effects. Addyi is the first drug approved to treat a weak or absent libido for women or men.
In June 2015, an advisory committee of outside experts recommended the approval of Addyi by a vote of 18 to 6. Recommended approval was conditional on precautions required to try to limit the risks and ensure that it was not overused.
Addyi, also known as flibanserin, has been called “pink Viagra.” Advocates who pressed for approval of Addyi, with many a part of a coalition called 'Even the Score', said that a drug to improve women’s sex lives was long overdue, given the numerous options available to men already.
Sprout is paying at least part of the expenses for 'Even the Score' with members including the National Council of Women’s Organizations, the Black Women’s Health Imperative and the Association of Reproductive Health Professionals.
Sprout said it would not advertise on radio or television for 18 months after Addyi’s approval, to allay concerns that the drug would be overused. Whitehead said the company plans to focus marketing on doctors, not consumers.
Sally Greenberg, executive director of the National Consumers League said, “This is the biggest breakthrough for women’s sexual health since the pill.”
Contributed by Millennium Traders
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