‘Female Viagra’ Drug Could Arrive by Summer

Photo (cc) by mrhayata

A drug referred to as the “female Viagra” is one step closer to market.

An advisory committee of the U.S. Food and Drug Administration voted Thursday afternoon to recommend that the FDA approve flibanserin with conditions, including proper warning labels and an education program, the Washington Post reports.

The FDA, the federal agency that approves and regulates prescription drugs, is expected to make a decision on the recommendation by the end of the summer.

The company behind flibanserin — Sprout Pharmaceuticals of Raleigh, North Carolina — describes the drug as “a treatment option for the unmet need of women with hypoactive sexual desire disorder (HSDD), or distressing low sexual desire.”

The company’s website states that it’s seeking FDA approval for use of flibanserin by premenopausal women, for whom there currently is no FDA-approved treatment for HSDD. Sprout Pharmaceuticals says it is ”focused solely” on creating such a drug.

Psychiatrist Dr. Stephen M. Stahl, an adjunct professor of psychiatry at the University of California, San Diego who also has a doctorate in pharmacology and has consulted for pharmaceutical companies, stated in a Sprout Pharmaceuticals press release earlier this year:

“The brain plays an important role in regulating a woman’s sexual desire, and one of the root causes of persistent and recurrent low sexual desire, or HSDD, stems from an imbalance of neurotransmitters in the brain.

Flibanserin is believed to work by correcting this imbalance and providing the appropriate areas of the brain with a more suitable mix of brain chemicals to help restore sexual desire.”

The results of a trial published in the Journal of Sexual Medicine in 2013 found that a nightly 100-milligram dose of flibanserin “resulted in significant improvements in the number of [sexually satisfying events] and sexual desire” compared with use of a placebo.

The FDA usually follows its advisory committees’ recommendations, the Washington Post reports. But the agency already has rejected flibanserin twice, citing potential side effects that include:

  • Fainting
  • Nausea
  • Dizziness
  • Sleepiness
  • Low blood pressure

The advisory committee that met Thursday described the drug’s benefits as “moderate” or “marginal.”

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