A New Drug for Female Sexual Dysfunction

Ordinarily The Medical Letter does not review new drugs before their price becomes available, but the FDA’s approval of bremelanotide (Vyleesi) for treatment of female sexual dysfunction created so much interest that we felt obliged to break that rule. An article on Vyleesi will appear in our July 29 issue, which is available online now.

Ever since the introduction of Viagra for erectile dysfunction in 1998, the pharmaceutical industry has been under pressure to introduce treatments for female sexual dysfunction, particularly low sexual desire, which has a high prevalence in both pre- and postmenopausal women. More than 20 years have passed, and Vyleesi will be (in September, according to the manufacturer) only the second drug marketed in the US for sexual dysfunction in women.

The indication itself may cause some confusion, because the new drug, like its only predecessor, was approved for hypoactive sexual desire disorder (HSDD), a diagnostic category that no longer exists in the most recent volume of The Diagnostic and Statistical Manual of Mental Disorders (DSM-5). It was replaced by sexual interest/arousal disorder (SIAD), which has somewhat different criteria that may lead to some difficult discussions with health insurers.

Flibanserin (Addyi), the first drug approved for treatment of HSDD, was reviewed in The Medical Letter in our September 28, 2015 issue. It was marketed as a tablet that had to be taken daily at bedtime. We concluded that it was not very effective and had some disquieting side effects, including hypotension, syncope, and central-nervous-system depression, which could be aggravated by concurrent drinking of alcohol. The need to restrict the use of alcohol severely limited the popularity of the drug.

Vyleesi, which must be injected subcutaneously, is not burdened by an alcohol contraindication, but it has some problems of its own. Now you can read about those on our website.

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