Just how big is the potential market for Addyi, the newly approved drug to boost women's libidos?
About one in 10 women suffer from hypoactive sexual desire disorder, or HSDD, according to Even the Score, a women's sexual health campaign that has advocated for the drug, called flibanserin. Other surveys have estimated the number of women who suffer from the disorder at as many as 8.6 million in the U.S. alone.
That could prove to be a large -- and lucrative -- pool of potential patients for Sprout Pharmaceuticals, the drug's manufacturer. Given the drug will cost between $30 to $75 a month, Sprout could end up raking in more than $120 million annually, if one assumes that half of the U.S. women with HSDD sign on and pay at least the lower end of the prescription cost. Given the interest in the drug, it's likely Sprout will get a boost in business when Addyi is rolled out in October. But some experts are predicting that women will eventually get turned off.
"A lot of prescriptions will be written and filled," Leonore Tiefer, clinical associate professor of psychiatry at NYU School of Medicine, predicted. Tiefer, who has opposed the drug, added, "The minuscule benefits and the very grave landscape of side effects will take their toll. I don't think the prescriptions will be renewed."
Sprout declined to comment, noting the privately held company doesn't disclose financial information.
The side effects aren't anything to sneeze at. They include low blood pressure, fainting, drowsiness and dizziness, especially when combined with alcohol. One in five women could experience an adverse side effect while taking Addyi, Georgetown University's Dr. Adriane Fugh-Berman told CBS News.
In fact, the FDA is advising that women who take the drug avoid alcohol completely given the risks, which include losing consciousness. That alone might be a deal-breaker for many people, Tiefer noted.
"No drug comes without side effects. I think that's very important. Addyi is no different than countless other drugs," Sprout CEO Cindy Whitehead told CBS This Morning on Wednesday.
On top of dealing with the side effects, the medication may not be all that effective. An FDA analysis of the drug found that only 8 percent to 13 percent of women reported their symptoms were "much improved" compared with those taking a placebo. The FDA had previously rejected the drug twice.
Not every woman using the drug will understand that the medication may not be all that effective, Tiefer said. "A lot of people who take drugs that don't work tend to blame themselves," she said. "The diagnosis itself -- and the fact that people don't think they are doing it enough, doing it right, that they don't want to have sex under the boardwalk -- it's created a market of insecurity."
So how did a drug that may not be all that effective and carries significant side effects get approved? Advocacy and marketing may have helped, given a savvy campaign that framed Addyi as a fight against gender discrimination. The push, which is backed by Sprout and women's groups including the National Organization for Women, pointed out that the FDA has approved 26 drugs designed to treat male sexual dysfunctions, compared with zero for women (prior to Addyi.)
"Equality isn't an equal number of drugs," Tiefer said. She believes drugs are not needed for low sexual desire. Instead, women and couples should try other methods, such as therapy, to resolve their issues.
Sometimes, Sprout's Whitehead told CBS This Morning, women need more help. "Sex is part of who we are. It's part of our relationships, for most of us, our marriages," she said. "And frankly, if something isn't going right, and it's medical, I believe that you should have medical treatments to address that."
In the meantime, Sprout is getting ready to grow. With sales of Addyi starting on Oct. 17, the company plans to expand its headcount to 200 employees, up from its current 34-person team, according to the Triangle Business Journal. Whitehead told the publication that the company will build a specialty sales force to educate physicians.