Apr 12, 2019, 11:55 ET

The Food and Drug Administration (FDA) Determines that Women Taking Addyi May Safely Consume Alcohol

Sprout continues to work with FDA to ensure other elements of labeling are in line with new study findings

RALEIGH, N.C., April 12, 2019 /PRNewswire/ -- 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."

Sprout Pharmaceuticals, Inc. is passionate about women's sexual health. Based in Raleigh, N.C., the company is focused solely on the delivery of a treatment option for women with HSDD. For more information call 1-844-PINK-PILL (1-844-746-5745).

Addyi is the first and only FDA-approved treatment for acquired, generalized hypoactive (low) sexual desire disorder (HSDD) for premenopausal women. In clinical trials, Addyi has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events. The most common adverse events among patients treated with Addyi were dizziness, somnolence, nausea, fatigue, insomnia and dry mouth. Hypotension, syncope, and central nervous system (CNS) depression were seen with Addyi alone and more frequently when co-administered with alcohol in the morning, or certain other drugs. Alcohol consumption within two hours of taking Addyi is contraindicated. With the FDA, Sprout Pharmaceuticals developed a comprehensive Risk Evaluation and Mitigation Strategy (REMS) program, including prescriber and pharmacist certification, to ensure safe use of Addyi. Addyi is a novel, non-hormonal oral pill to be taken at bedtime. See full prescribing information, including Boxed Warning regarding the use of alcohol, severe low blood pressure, and fainting in certain settings, at addyi.com/pi.

844-746-5745 x 2000