Results from 3 studies evaluating the interaction between Addyi (flibanserin; Sprout), a treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, and alcohol have been submitted to the Food and Drug Administration (FDA) for review for inclusion in the product labeling.

Controversy has surrounded Addyi, a 5-HT1A agonist/5-HT2A antagonist, since its launch in 2015, after it faced the FDA’s advisory committee panel for review of efficacy and safety issues a total of 3 times before approval. The treatment currently carries a Boxed Warning for an increased risk of severe hypotension and syncope when taken with alcohol.

The 3 studies were conducted to further investigate the interaction between Addyi and alcohol. In the first study (N=24), none of the women who took Addyi approximately 2.5 hours after having an evening meal which included alcohol (2 servings) experienced syncope following bedtime dosing. The second study (N=96), which examined a worst-case scenario where the patient consumed 2-3 shots of grain alcohol mixed with orange juice with Addyi, resulted in no episodes of syncope or orthostatic hypotension requiring medical intervention. In addition, a dose-timing study revealed that women who consumed alcohol (2 drinks) 2, 4, or 6 hours prior to taking Addyi did not experience episodes of syncope or orthostatic hypotension requiring medical intervention.

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“The additional insights provided by these 3 new studies are invaluable for a more comprehensive understanding of Addyi for safe use,” said Cindy Eckert, Founder and CEO of Sprout Pharmaceuticals. “This additional data contextualizes and further clarifies the relationship between Addyi and alcohol.”

For more information visit Addyi.com.

This article originally appeared on MPR