FDA: Those worries about Addyi and alcohol? We can handle it

During clinical studies of the female libido drug flibanserin, a 54-year-old woman taking the drug died of "acute alcohol intoxication." Her blood alcohol level was 3.5 times the legal limit, but with daily doses of the drug to consider--with well known alcohol-related symptoms of central nervous system depression and severe hypotension--a senior regulator at the FDA concluded that "it is not possible to exclude a role of flibanserin in this patient's death."

It was possible, though, for the agency to approve the drug, which will soon be marketed by Valeant ($VRX) as Addyi, after acquiring the drug in a $1 billion buyout.

Dr. Hylton Joffe

That interaction between the drug and alcohol was a major concern at the FDA, as regulators balanced the risks posed by a drug that they knew had only a modest impact on improving the number of sexually satisfying events in the average month of women who suffered from a chronic absence of such experiences. Looking at the broad data available for the review, the overall improvement in satisfaction scores hovered around 10% compared to placebo, noted Dr. Hylton Joffe, director of the Division of Bone, Reproductive and Urologic Products at the FDA, in a memo dated August 18.

As Bloomberg first reported today, the memo covers an internal discussion at the FDA over the controversial drug, including a hesitation on one reviewer's part to approve a female sexual dysfunction drug with a known interaction risk with alcohol, when most of the subjects recruited for the safety trial were men.

Joffe, though, concluded that a slate of postmarketing studies along with a program requiring prescribing doctors and pharmacists to consistently warn women to avoid alcohol while taking the daily drug was sufficient to warrant an approval for the first such drug to hit the market.

There's also little doubt, though, that a large number of women in the target population for this drug will continue to drink.

"According to the Centers for Disease Control and Prevention (CDC), among non-pregnant women 18-44 years of age in the United States (2006-2010), approximately 50% reported drinking alcohol within 30 days of taking the self-reported survey and approximately 15% reported binge drinking (four or more drinks on one occasion) at least one time during that same timeframe," writes Joffe.

The controversy over Addyi is only likely to heat up once Valeant starts to make the drug available in a few weeks. Joffe's review noted the public lobbying campaign for the drug by Even the Score in his review, along with the public comments and direct appeals it had received. But a number of women's groups were also opposed to an approval, highlighting the risk factors. Any new interactions between the marketed drug--often misleadingly referred to in the media as a "female Viagra," even though it works in a completely different fashion--and alcohol are likely to gain quick attention for a drug that remains a lightning rod for public attention.

After all, Joffe noted in his overview, the FDA can take further action on Addyi after it hits the market, if it's warranted. 

- here's the memo
- here's the Bloomberg report

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