After having been twice rejected by the FDA, Sprout Pharmaceuticals Inc.'s Addyi (pronounced add-ee), touted as "female Viagra" has finally received the regulatory agency's thumbs up to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women, which is the most common form of female sexual dysfunction.
Hypoactive sexual desire disorder, or HSDD, is a persistent or recurrent decrease or lack of sexual desire that causes distress for the patient, may put a strain on relationships with partners, and is not due to the effects of a substance, including medications, or another medical condition.
Initially developed by Boehringer Ingelheim, Addyi (flibanserin 100 mg) was slapped with a Complete Response Letter in 2010. The following year - in 2011 - Sprout Pharmaceuticals acquired Addyi from the German drug maker. Sprout Pharma resubmitted the NDA for Addyi in February 2013, which included 14 new clinical studies with data on more than 3,000 new patients. However, the second time too proved unlucky, with the FDA issuing a Complete Response Letter again for Addyi in December 2013.
Addressing the concerns raised by the FDA in its 2013 Complete Response Letter, Sprout Pharma resubmitted the NDA for Addyi, including results from a phase 1 pharmacokinetic study and a phase 1 driving study, in February 2015.
An FDA panel, which reviewed the NDA for Addyi on June 4, 2015, voted 18 to 6 recommending approval of the drug. Following the panel's recommendations, the FDA gave its green signal to Addyi today (August 18, 2015).
Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body, warns the FDA.
Approved with a risk evaluation and mitigation strategy, Addyi, which is the first and only FDA-approved treatment for HSDD, is anticipated to be available by October 17, 2015.
by RTTNews Staff Writer
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