Wait Will Continue for ‘Female Viagra’ Flibanserin

flibanserin

Those waiting for the highly anticipated medication flibanserin, known to many as the “female Viagra,” to enter the market will continue to wait for now, thanks to the U.S. Food and Drug Administration (FDA). The FDA told the drug’s manufacturer, North Carolina-based Sprout Pharmaceuticals, that it would like to see some more human research on the effects of flibanserin before giving the green light for mass release.

The drug is considered an experimental treatment for Hypoactive Sexual Desire Disorder (HSDD) in women and is intended to boost the female sex drive and alleviate the emotional difficulties that may accompany a low sex drive for some. It will be the first drug of its kind to hit the market if it receives FDA approval and will mark the end of a 15 year journey by the pharmaceutical industry to get such a drug approved for women.

To have that approval considered, the FDA says that Sprout will need to do additional research in three specific areas. Potential interactions with other medications need to be closely looked at, as well as whether flibanserin interferes with users’ ability to drive or causes excessive sleepiness. Approximately 10 percent of those who have taken the drug during its developmental stage have reported sleepiness as a significant side effect. Sprout says that it hopes to complete the three relatively small studies and resubmit for approval in the fall.

The drug was rejected from approval previously in 2011, due to a lack of convincing evidence that it does indeed act as the manufacturer states that it does in improving the female sex drive. Concerns about serious side effects such as dizziness, fatigue and nausea were also raised at that time.

A spokeswoman for Sprout has said that the company is optimistic about future approval and is determined to get the product on the market, in part because women suffering with HSDD currently have few alternatives. Flibanserin is believed to work by interfering with certain neurotransmitters in the brain that are associated with mood, appetite, and sexual desire or a lack thereof.

Even if approved, flibanserin and Sprout Pharmaceuticals may face an uphill battle and immense costs when it comes to  marketing the proposed daily medication. Many medical professionals are skeptical as to its efficacy and may be reluctant to prescribe it. Unlike in males, for whom Viagra may offer a simple solution to a purely physical problem, before diagnosing women with HSDD, doctors are likely to try to rule out a host of other possible explanations for lowered sexual interest including depression, relationship problems and hormone imbalances. Additionally, the drug would be recommended only to pre-menopausal women, so those suffering from HSDD post-menopause would still be left without a prescription solution for the problem.

The popular male sexual dysfunction drug Viagra, entered the market in 1998 to an unprecedented welcome and has since seen competition from other manufacturers trying to cash in on its success as well. Unfortunately, the race to develop a similar alternative for females has been ongoing for years. Today’s FDA decision means that those anxiously awaiting the release of the so-called female Viagra, flibanserin, will continue to wait at least a little bit longer.

By Michele Wessel

Sources:

TIME

CBS

WebMD

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