A new Viagra-like pill for women was rejected by the U.S. Food and Drug Administration, and now the manufacturer is making an appeal.
The pill, called flibanseri, is being pushed by Sprout Pharmaceuticals Inc. It would treat women whose low-libidos affect their lives and relationships, Bloomberg BusinessWeek reported.
In clinical trials the pill was effective at almost doubling the amount of "satisfying sexual experiences" over the course of a month, compared with participants who were given the placebo.
"I do believe that women deserve a solution to their most common form of sexual dysfunction," Cindy Whitehead, president and chief operating officer at Sprout, told Bloomberg. "Flibanserin has been in 11,000 patients at this point. It's pretty well defined."
Viagra was used to treat male sexual dysfunction 15 years ago; since then treatments for similar disorders in women has been lacking.
"Women's sexual health has been really underground," Sheryl Kingsberg, chief of the Division of Behavioral Medicine at Case Medical Center, said, Bloomberg reported. "One reason that women's sexual desire has lagged is desire is in the brain."
This new drug could help solve some of these problems; the drug is non-hormonal and resembles an antidepressant.
The manufacturer gave flibanseri to 11,000 women and asked them to count the number of satisfying sexual encounters they experienced over the month-long period.
"I think this could be a blockbuster drug," Whitehead said.
The women who were given flibanseri saw an increase in sexually satisfying experiences of 2.5 compared to the placebo group that increased them by 1.5.
The drug can cause side effects such as "fatigue, nausea and sleepiness," Bloomberg reported.
"I think the patient can assess the benefit to them and talk to their doctor about it," Whitehead said.
About one in 10 women experience lack of sexual desire accompanied by sex-related stress. Forty-three percent of all women will experience some type of sexual dysfunction in their lifetime.
