Sprout Pharmaceuticals, Inc. develops and offers products for treatment of female sexual health. It offers a non-hormonal pill for the treatment of acquired and generalized hypoactive sexual desire disorder in premenopausal women in the United States. The company was founded in 2011 and is based in Raleigh, North Carolina. As of October 1, 2015, Sprout Pharmaceuticals, Inc. operates as a subsidiary of Valeant Pharmaceuticals International, Inc.
4208 Six Forks Road
Raleigh, NC 27609
Founded in 2011
Sprout Pharmaceuticals, Inc. Announces Addyi
Oct 19 15
Sprout Pharmaceuticals, Inc. announced 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. The company will offer two avenues of affordable access for women, including the Addyi Affordable Access Card for pharmacies and the AddyiDirect program with doorstep delivery. 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.
Sprout Pharmaceuticals Receives U.S. Food and Drug Administration Approval of Addyi (Flibanserin 100 mg)
Aug 18 15
Sprout Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has granted approval of Addyi (flibanserin 100 mg) (pronounced add-ee), a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Addyi is the first and only FDA-approved treatment for this condition, the most common form of female sexual dysfunction, affecting up to 1 in 10 women in the United States. HSDD is defined as a persistent absence of sexual thoughts, fantasies, responsiveness and willingness to engage in sexual activity that causes personal or relationship distress and cannot be accounted for by another medical condition or substance. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.
Sprout Pharmaceuticals, Inc. - Special Call
Aug 18 15
To discuss on U.S. Food and Drug Administration approval of Addyi™ (flibanserin 100 mg) (pronounced add-ee)