U.S. markets open in 2 hours 1 minute

FDA Removes Alcohol Ban with Addyi - the First-and-Only Non-Hormonal Treatment for Hypoactive (Low) Sexual Desire Disorder (HSDD)


Women seeking treatment for the most common form of female sexual dysfunction, Hypoactive (low) Sexual Desire Disorder (HSDD), now have greater access to the medical treatment Addyi 

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

ABOUT ADDYI
Addyi is the first-and-only non-hormonal FDA approved treatment for acquired, generalized Hypoactive (low) Sexual Desire Disorder (HSDD) for premenopausal women. Addyi is the only treatment for HSDD that has successfully demonstrated that it adds more satisfying sexual events, adds more desire for sex and reduces distress from the loss of sexual desire in clinical trials. The most common adverse events among patients treated were dizziness, sleepiness, nausea, fatigue, insomnia and dry mouth. Patients are advised to discontinue drinking within two hours of taking Addyi at bedtime or skip the Addyi dose that evening. Addyi is a novel, non-hormonal pill. See full prescribing information and medication guide at addyi.com/pi.

CONTACT INFORMATION
media@sproutpharma.com
844-746-5745 x 2000

Cision

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