Presented at The International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting, results from three pivotal, randomized, placebo-controlled trials assessing efficacy of Addyi in treating premenopausal women with Hypoactive Sexual Desire Disorder, or HSDD, show clear benefits in multiple areas of female sexual function in as early as 4 weeks and maintained for duration of treatment.
| ORLANDO, Fla., March 5, 2020 /PRNewswire/ --Sprout Pharmaceuticals, Inc. (“Sprout”) announced today that it will present new data combined from three pivotal trials showing Addyi’s statistically significant improvement on desire, lubrication, arousal, orgasm and satisfaction. Addyi is the only FDA approved non-hormonal pill proven safe and effective to treat acquired, generalized Hypoactive (low) Sexual Desire Disorder, or HSDD, in premenopausal women. These newly presented findings examined Addyi’s medical benefit to women across the spectrum of sexual function.
For these three pivotal trials, subjects diagnosed with HSDD were randomized to receive either Addyi® (flibanserin) 100mg or placebo for a 24-week period. The assessment of sexual function changes is based on the widely used and clinically validated Female Sexual Function Index (FSFI) which measures female sexual function in six distinct areas. Patients in the Addyi group showed a statistically significant increase over the patient’s baseline measurement. While variations in response times should be considered, the beneficial impact of Addyi on women’s sexual function occurs within the first month and was maintained throughout the 24-week study time period. “These findings paint a much fuller picture of the treatment outcomes patients may experience with Addyi. Addressing the desire issues of HSDD can cascade to better arousal, lubrication and orgasms,” said James A. Simon, MD, Clinical Professor at George Washington University and President, IntimMedicine Specialists. “It’s no surprise that these aspects of the sexual experience can be interrelated so improving one can improve the others.” “With the next frontier of wellness being sexual wellness, we stand proud in leading the charge for evidence-based solutions to address women’s common sexual struggles,” said Cindy Eckert, Sprout Pharmaceuticals CEO. “These findings continue to excite us about Addyi’s significance in addressing a common need for women and pioneering a new category to serve them.” Addyi’s current indication to treat HSDD in premenopausal women was the result of phase 3 clinical findings demonstrating an increase in women’s desire for sex, an increase their number of satisfying sexual events while on treatment and decrease for their related distress. The most common side are dizziness, nausea, tiredness, difficulty falling asleep or staying asleep and dry mouth. HSDD is the most common form of sexual dysfunction for women. 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 delivery of a treatment option for women with HSDD. For more information call 1-844-PINK-PILL (1-844-746-5745). ABOUT ADDYI Addyi is the first and only FDA-approved non-hormonal pill 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, nausea, tiredness, difficulty falling asleep or staying asleep and dry mouth. Patients are advised to wait 2 hours after consuming 1-2 alcoholic drinks before taking their Addyi at bedtime or skip their dose if they’ve had 3 or more drinks that evening. Addyi is a novel, non-hormonal pill. See important safety information, including BOXED WARNING regarding low blood pressure and fainting in certain settings, and full prescribing information at addyi.com/pi. CONTACT INFORMATION
SOURCE Sprout Pharmaceuticals, Inc. |
View original content to download multimedia: