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‘Female Viagra’ wins approval from FDA expert panel

A drug developed to increase female libido is a step closer to being approved in the United States. 

Flibanserin, a 5-HT1A-receptor agonist and 5-HT2A-receptor antagonist, which has been dubbed the “female Viagra”, won approval on 4 June 2015 by a joint committee expert panel for the Food and Drug Administration (FDA). The panel was assessing the drug’s risks and benefits in the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD). 

The panel agreed by 18 votes to 6 votes that the overall benefit/risk profile was acceptable and the outcome will form part of the ongoing FDA review of the drug. 

“We are one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction,” according to a spokesperson for Sprout Pharmaceuticals, based in North Carolina, which plans to market the product as Addyi. 

The drug has already twice failed to be recommended for approval by FDA experts — in 2010 and in 2013 following concerns about its efficacy and safety. 

The latest FDA briefing document considered by the agency’s bone, reproductive and urologic drugs advisory committee and the drug safety and risk management advisory committee acknowledged the difference the drug would make to women. 

“There are no medications that are FDA approved for the treatment of HSDD… The FDA has recognized for a long time that there are women who have reduced sexual desire that causes distress, and who would benefit from safe and effective treatment,” the report said. 

“This condition is clearly an area of unmet medical need. However, for any product intended to treat an unmet medical need, the FDA is still required to base its regulatory decisions on an assessment of whether the benefits outweigh its risks. This has been the FDA’s approach with flibanserin, which has a challenging benefit/risk assessment.” 

An additional report also considered by the joint committee from the FDA’s division of risk management highlighted the potential risk of low blood pressure/syncope associated with the drug – which is exacerbated when it’s taken in conjunction with alcohol – and the steps that could be taken to reduce, but not eliminate them. 

A spokeswoman for the FDA confirmed that the vote of the joint committee will be considered by the agency as it continues its review of the drug. The product, should it be eventually approved, would be taken as a 100mg tablet orally once daily at bedtime.

Citation: The Pharmaceutical Journal http://www.pharmaceutical-journal.com

 

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