Sprout Pharmaceuticals says it’s got a winner. The pharmaceutical company believes it’s created a female version of Viagra, but the FDA isn’t convinced. The FDA asked for more research, but Sprout Pharmaceuticals is fighting back, saying they have provided enough information already.
It’s not the first time the FDA said no
The FDA denied the drug, flibanserin, in June 2010. Since that time, the pharmaceutical company conducted more clinical trials in an effort to beef up the results.
According to CBS News, the company added 14 new clinical studies with data on more than 3,000 new patients and re-submitted its application. In total, more than 11,000 women have tried out the drug. More than 5,000 subjects were enrolled in phase III trials, which marks the final stage of efficacy and safety testing.
“Sprout strongly believes that it has satisfied the statutory requirements for approval of flibanserin,” Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals, said in a press release.
The FDA will look into the appeal next year. Last year, just three appeals out of 17 were approved.
The need for a female Viagra
Men have a variety of options to improve libido. In fact, the fifth erectile dysfunction medication Stendra, will be released next year. Yet, women don’t have any oral medications to choose from.
According to WebMD, about 43 percent of women experience some kind of sexual problem, but few have treatments.
Most pharmaceutical companies have abandoned drugs for female sexual disorders. The maker’s of Viagra quit attempting to create a female Viagra in 2004. BioSante Pharmaceticals was testing a gel to improve a woman’s sex drive, but it failed in two large studies.
Studies indicate filanserin has some success. In one study, 18 percent of women had an improved sex drive while taking the drug.
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