Sprout Pharmaceuticals, Inc. (Sprout), a division of Valeant Pharmaceuticals North America LLC, announced today that Addyi, a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, is now available in the United States through certified physicians and pharmacies. Addyi was approved by the U.S. Food and Drug Administration (FDA) on August 18, 2015.
"Finally, all women who have been waiting for a medical treatment option can now make their own decision with their healthcare provider if Addyi is right for them," said Sprout Pharmaceuticals Chief Executive Officer Cindy Whitehead. "With our availability nationwide today, we are proud of our affordable and innovative programs to offer Addyi for as little as $20 per prescription."
Sprout will offer two avenues of affordable access for women, including the Addyi Affordable Access Card for pharmacies and the AddyiDirect program with doorstep delivery. For more information about both programs, visit www.Addyi.com or visit your healthcare provider. Addyi is available through certified health care prescribers and pharmacies enrolled in the Addyi Risk Evaluation and Mitigation Strategy (REMS) program. The Addyi REMS certification and enrollment materials can be accessed via www.Addyi.com in the REMS section.
"Acquired, generalized HSDD is the most common sexual complaint that I see among women in my practice, so having Addyi as an option for them is game changing. It's my belief that Addyi marks a new era for women and couples to have an honest conversation about what's happening for her in the bedroom. I think we'll see the positive effects of this dialogue well beyond medicine," said Dr. Karen Boyle, urologic surgeon at Chesapeake Urology Associates at Greater Baltimore Medical Center.
The approval of Addyi is largely based on three North American, Phase 3, 24-week, randomized double blind, placebo-controlled studies of premenopausal women with HSDD. Addyi was administered to over 2,500 premenopausal women with acquired, generalized HSDD in clinical trials, with over 850 receiving treatment for at least 12 months. For premenopausal women with HSDD, Addyi has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events.
Addyi is not indicated for use in postmenopausal women or men or to enhance sexual function. Addyi was approved with a Boxed Warning. Use of Addyi with alcohol increases the risk of severe hypotension and syncope; therefore, alcohol use is contraindicated. Severe hypotension and syncope occurs when Addyi is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore use of Addyi in patients with hepatic impairment is also contraindicated. Hypotension, syncope and central nervous system (CNS) depression can occur with Addyi alone. The most common adverse reactions are dizziness, somnolence, nausea, fatigue, insomnia and dry mouth. See full safety information below. Addyi is intended to be administered orally once per day at bedtime with or without food.