Update 9/11/2019: Sprout Pharmaceuticals has posted a timeline of events on their website regarding regulatory guidance for Addyi. According to the timeline, the FDA had objected to Sprout’s press release discussing the removal of the alcohol contraindication and REMS requirements and had asked the Company to take it down on September 6th. 

“FDA was concerned that Sprout’s original press release could lead to confusion among stakeholders,” said Amanda Turney, a spokesperson for the FDA. “Accordingly, we want to clarify that at this time FDA has not approved new labeling for Addyi and has not approved a supplement removing any element of the REMS.”

9/10/2019: MPR recently published an article about the removal of the alcohol contraindication and Risk Evaluation and Mitigation Strategy (REMS) requirements for Addyi (flibanserin; Sprout Pharmaceuticals). We have recently learned that at this time, the Food and Drug Administration (FDA) has NOT revised its warnings about the use of alcohol with Addyi nor has it changed the drug’s REMS, according to an FDA spokesperson.

A press release, issued by Sprout Pharmaceuticals and titled “FDA Removes Alcohol Ban with Addyi – the First-and-Only Non-Hormonal Treatment for Hypoactive (Low) Sexual Desire Disorder (HSDD)” was recently removed from the Company’s website. However, labeling that does not include the alcohol contraindication or the REMS requirements continues to surface on Addyi.com

Addyi, a 5-HT1A agonist/5-HT2A antagonist, is indicated for the treatment of premenopausal women with acquired, generalized HSDD, as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. 

Based on the original product labeling, the use of Addyi and alcohol is contraindicated as it may increase the risk of severe hypotension and syncope. Because of the increased risk of hypotension and syncope due to an interaction with alcohol, Addyi is available only through the Addyi REMS program.

In April 2019, after a review of postmarketing studies, the FDA had determined that while the use of alcohol does not have to be avoided completely, consuming it close in time to Addyi still posed a risk. The Agency had requested that the Boxed Warning, Contraindication, Warnings and Precautions and Adverse Reactions sections of the labeling be updated to reflect that women should discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or to skip the dose that evening; women should also not consume alcohol at least until the morning after taking Addyi at bedtime. The Agency, however, could not come to an agreement on these safety labeling changes with the Company, which continued to request the removal of the alcohol contraindication and boxed warning.

MPR will continue to follow-up on this story as more information becomes available.

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