FDA approval of ‘female Viagra’ divides medical professionals; Expert sees poor sales of Addyi after 6 months due to side effect
As expected, the US Food and Drug Administration, or FDA, approval on Tuesday of Sprout Pharmaceutical’s libido boosting drug, Addyi, divided the medical community. The drug flibanserin, which is its generic name, is also popularly called “female Viagra.”
Even before the FDA gave the drug the green light, Leonore Tiefer, clinical associate professor of psychiatry at the New York University’s School of Medicine, thinks flibanserin is a disaster, unsafe and doesn’t work. Tiefer says she opposed it as early as 2010. She criticises Sprout’s alleged illegitimate means to get FDA approval by using the argument of sexism, reports Time.
Dr Adriane Fugh-Bergman of Georgetown University, in a June FDA committee hearing, warned FDA approval of the drug would set the worst kind of precedent. In another FDA testimony, Christina Silcox, PHD fellow at the National Center for Health Research, said that flibanserin has a substantial placebo effect and very small benefit that warrants an FDA disapproval.
On the other hand, Cleveland Clinic women’s health specialist Dr Holly Thacker sees the drug as “one of the top health innovations for the coming year,” while MD Anderson Cancer Center assistant professor of gynecologic oncology and reproductive medicine, sees cancer survivors, who have lost their sex drive, accept flibanserin with enthusiasm and high hopes.
While Dr Mary Jane Minkin, clinical professor of obstetrics, gynecology and reproductive services at Yale School of Medicine, says it is not a fabulous drug, “It’s for someone else to decide if nausea is worth more than libido.”
Besides doctors’ opinion, what will determine really if Addyi is effective would be female consumers when the drug becomes available in pharmacies on Oct 17. An expert forecasts flibanserin would not make so much money but pave the way for similar drugs.
Raguran Selvaraju, managing director of brokerage H.C. Wainwright & Co, predicts Addyi’s peak annual sales would hit $100 million only, in contrast to Viagra’s $1.3 billion. Selvaraju explains, “This drug is not going to provide a dramatic or meaningful improvement to a woman’s sex life, so why would you take it with all those side effects?”
He foresees high sales during the first six months because of pent-up demand, but Selvaraju warns women would eventually abandon flibanserin because of the side effects. For Sprout, the impact is income from Addyi would likely cover only costs of developing the drug.
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