Sprout Pharmaceuticals has resubmitted a new drug application to the FDA for flibanserin, an investigational therapy to treat hypoactive sexual desire disorder in women during premenopause, according to a news release from the company.
After receiving a Complete Response Letter from the agency in 2013, and responding with an appeal, the pharmaceutical company was asked to complete pharmacokinetic and driving studies; results from these phase 1 trials were included with the resubmission.
Flibanserin would be the first and only treatment for hypoactive sexual desire disorder (HSDD) if approved by the FDA.
“The brain plays an important role in regulating a woman's sexual desire, and one of the root causes of persistent and recurrent low sexual desire, or HSDD, stems from an imbalance of neurotransmitters in the brain,” Stephen Stahl, MD, PhD, adjunct professor of psychiatry, University of California San Diego, School of Medicine, said in the release. “Flibanserin is believed to work by correcting this imbalance and providing the appropriate areas of the brain with a more suitable mix of brain chemicals to help restore sexual desire.”
In three phase 3, randomized, double-blind, placebo-controlled, parallel-group trials in North America, researchers evaluated the safety and efficacy of flibanserin in premenopausal women with a mean age of 36 years.
Compared with placebo, the therapy significantly increased sexual desire, decreased distress from the loss of sexual desire and increased the frequency of satisfying sex. Dizziness, nausea and sleepiness were the most common side effects of the drug.