Thursday, 23 Jan 2020

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Female "Viagra Pill" Controversy - Grandstanding or Equal Rights?

The FDA is under pressure over the recent approval of the "female viagra" pill.  On August 18th, the FDA announced its approval for Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.  This latter issue became one of the dominant themes during the FDA advisory board that preceded the decision.  

The theme presented by the manufacturers was "26-0", meaning there were 26 approved drugs for male libido and none for women.  In addition there were many impassioned pleas for approval from patients and others during the open forum presentations. 

Despite the "unmet need" for such therapy, insurers and reviewers have remarked that the evidence for the drugs efficacy is minimal and that there is a problematic interaction with alcohol that requires more study. For instance, In these trials, treatment with flibanserin increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo, increased the sexual desire score by 0.3 to 0.4 over placebo, and decreased their (sexual) distress score related to sexual desire by 0.3 to 0.4 over placebo.

Like Viagra, it is unlikely that this medication will be covered by insurance. Moreover, physicians who wish to prescribe it will be required by the FDA to complete an online training program to be authorized to prescribe it, and patients will be required to sign a form acknowlegingthe risks.

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

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