Sprout Pharmaceuticals Denied In Attempt To Manufacture First Pill Treating Low Sexual Desire In Females
ByThere is currently no legal pill on the market to treat low sexual desire in females. There still isn't after the U.S. Food and Drug Administration (FDA) rejected an attempt by Sprout Pharmaceuticals, Inc., Bloomberg Business Week reported.
The FDA turned down Sprout's answer to the 24 federally-approved male treatments because of a "modest effect," according to Bloomberg. Basically, the government didn't believe the drug created a significant enough sexual response in females, despite clinical trials that said otherwise. According to the company, women had twice as many satisfying sexual experiences during the month they took Sprout's pill compared to a group taking a placebo version, Bloomberg reported.
"I do believe that women deserve a solution to their most common form of sexual dysfunction," Sprout president and chief operating officer Cindy Whiteheads said. "Flibanserin has been in 11,000 patients at this point. It's pretty well defined."
Fliberanserin describes females who experience stress because of low sexual desire. Sprout's solution is non-hormonal, instead operating on the basic principles that fuel antidepressants such as lowering serotonin levels in the brain and increasing dopamine and norepinephrine, according to Bloomberg. Its side effects include fatigue, nausea, and sleepiness.
"I think the patient can assess the benefit to them and talk to their doctor about it," Whitehead said.
Whitehead believes her company's creation could be a "blockbuster drug," considering male sexual treatment was a $4.4 billion industry in 2012, according to Bloomberg.
Sprout still has a chance of hitting that Blockbuster. It filed for an appeal on Dec. 3 and is awaiting the FDA's response. Though appeals are typically denied, Whitehead hopes to hear the reasons behind that decision and ways to manufacture an approved drug.
It may seem like the FDA is favored toward the treatment of male sexual disorders -- they approved a procedure to correct for detrimental curvatures in men's penises on Dec. 6 -- but the organization intends to hold a meeting in either 2014 or 2015 with the patient's perspective in mind, one perspective coming from females with sexual disorder.