FDA Removes Alcohol Ban with Addyi - the First-and-Only Non-Hormonal Treatment for Hypoactive (Low) Sexual Desire Disorder (HSDD)
RALEIGH, N.C., Sept. 4, 2019 /PRNewswire/ -- Sprout Pharmaceuticals (Sprout) announced today that the U.S. Food and Drug Administration (FDA) has removed their contraindication, or ban, on alcohol use with Addyi® (flibanserin), the first-and-only approved non-hormonal pill for acquired, generalized HSDD in premenopausal women.
FDA stated that patients should discontinue drinking alcohol at least two hours before taking Addyi. FDA also removed the requirement – under its Risk Evaluation and Mitigation Strategy (REMS) program – for healthcare practitioners or pharmacies to be certified to prescribe or dispense Addyi. To make all labeling elements consistent with the FDA's findings, the Boxed Warning will change. The Medication Guide will be updated and now included under the REMS. These important steps serve to better inform healthcare professionals and consumers alike on Addyi's safe use while improving access for the millions of women who suffer from this condition.
"This is an important day for Addyi and for the treatment of the most common form of female sexual dysfunction, HSDD," said James A. Simon, MD, Clinical Professor at George Washington University. "With the data and science on its side, it's not surprising to see the FDA remove an unnecessary alcohol contraindication and certification requirement. HSDD is a condition that can negatively impact relationships, self-esteem and quality of life. Improving access to treatment with Addyi for the millions of women suffering represents a major milestone in women's health."
"It's a new day for women," said Cindy Eckert, CEO of Sprout Pharmaceuticals. "As the first-and-only FDA approved non-hormonal treatment for HSDD in premenopausal women, Addyi offers a critical treatment option to help those struggling with this condition. No longer are women stuck choosing between treatment and a glass of wine. Outside of the day we broke through with the first approval in this category, this represents the biggest shift toward greater access for women in need."
To see if Addyi is an appropriate course of treatment, women will now be able to speak with any licensed U.S. healthcare provider to obtain a prescription for Addyi. Women can do this through office visits or via addyi.com where they can speak to a doctor licensed in their state via telephone from the privacy of their home. Women have the option to try their first eight weeks of Addyi for free.
ABOUT SPROUT PHARMACEUTICALS
View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-removes-alcohol-ban-with-addyi--the-first-and-only-non-hormonal-treatment-for-hypoactive-low-sexual-desire-disorder-hsdd-300911181.html
SOURCE Sprout Pharmaceuticals