A Raleigh drugmaker working to develop a pill to boost sexual desire in women has resubmitted its drug application to the Food and Drug Administration.
Sprout Pharmaceuticals announced Tuesday that it had resubmitted its application for flibanserin after completing additional clinical studies requested by the FDA.
Sprout is seeking to have flibanserin approved to treat Hypoactive Sexual Desire Disorder, or HSDD, in premenopausal women. It would be the first drug approved to treat the condition, which Sprout describes as a form of sexual dysfunction that is defined by an absence of desire for sexual activity.
Last year, the FDA requested more data on how the company’s drug interacts with medications and how it affects a person’s driving ability.
“The FDA has devoted significant resources to understand HSDD and the need for medical treatment,” CEO Cindy Whitehead said in a statement. “I believe that the Agency’s efforts to bring together panels of patients and clinical experts will prove to be a significant step in bringing about a solution for women with HSDD to market.”