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New drug application for flibanserin will be resubmitted to the FDA
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The company responsible for flibanserin, a drug for treatment of hypoactive sexual dysfunction disorder, or HSDD, in premenopausal women, announced it will resubmit a new drug application for FDA approval after initiation of requested phase 1 studies.
“We are encouraged by the FDA’s response and view it as a significant step toward the approval of flibanserin,” Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals, said in a press release. “With data in over 11,000 patients to date, we are confident that further supporting the predictable risk/benefit profile of flibanserin will result in women having the first ever treatment for the most common form of female sexual dysfunction. We are committed to working closely with the Agency to finally provide premenopausal women affected by HSDD with a medical treatment option.”
In December 2013, the Formal Dispute Resolution was filed with the FDA and the agency has requested two additional phase 1 drug interaction studies and a phase 1 driving simulator study, each to include 25 to 50 healthy participants. According to the press release, the studies will seek to answer interaction questions and identify any driving impairment, as previous studies reported 9.8% of women experienced drowsiness while taking flibanserin 100 mg.