SPROUT PHARMACEUTICALS, INC.: The Food and Drug Administration (FDA) Determines that Women Taking Addyi May Safely Consume Alcohol


Sprout Pharmaceuticals, Inc. issued the following announcement on April 12.

Sprout Pharmaceuticals is pleased to announce that the FDA has decided that existing warnings and restrictions regarding alcohol use in women taking Addyi® (flibanserin) for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) are overly restrictive and overstate the risk of alcohol interaction. This decision was informed by three new Addyi alcohol interaction studies which demonstrated no syncope or orthostatic hypotension requiring medical attention. This data has been presented to the International Society for the Study of Women's Sexual Health, International Society for Sexual Medicine and Sexual Medicine Society of North America and was submitted to the FDA eight months ago.

Sprout received the FDA ordered Addyi labeling change to lessen the alcohol restriction on April 11, 2019. The label change, once implemented, will ensure that healthcare providers and patients alike have confidence to make accurate, informed treatment decisions with study findings. Sprout Pharmaceuticals has chosen to continue discussions with the FDA to ensure all elements of labeling are equally in line with all known scientific data through a standard appeal process. This includes the now, inconsistent REMS program that requires healthcare providers and pharmacies to be certified to prescribe or dispense Addyi and women to sign a consent they will not drink when given a prescription for the drug.

"The FDA labeling revisions, and additional changes that Sprout is continuing to discuss with the FDA, should finally allow women suffering from HSDD much greater access to the only approved treatment, Addyi," said Cindy Eckert, Chief Executive Officer of Sprout Pharmaceuticals. "FDA, like us, recognizes that women want access to treatment for this condition and their label order reflecting that women taking Addyi may safely consume alcohol is a positive step. We are encouraged to continue to work with them so that all of Addyi's labeling elements are consistent with the safety and tolerability findings."

Original source can be found here.

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