The FDA finally ended the debates over flibanserin, which would help in treating hypoactive sexual desire disorder in premenopausal women, by releasing it decision today. The FDA through Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER), stated on their website that;
"Today's approval provides women distressed by their low sexual desire with an approved treatment option. The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction."
The said drug from Sprout Pharmaceuticals would be marketed under the brand name Addyi. Though the drug was approved, the said agency imposed an unusual number of restrictions as a move to minimize its side effects. Dr. Woodcock on his FDA statement said that;
"Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies. Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment."
However such approval was said to be a product of pressure to the agency. For a fellow doctor, Dr. Philip Hanno, a urologist at the University of Pennsylvania's school of medicine and one of the FDA advisers who voted against recommending approval of Addyi last June, said on an interview with NBC that;
"I think the FDA was under a lot of pressure. This 'Even the Score,' the group which apparently was supported by the pharmaceutical company among others, was very influential and they certainly had a lot of people at the advisory committee meeting who made comments."
And on similar NBC report, critics cited that Addyi should not be approved because of its side effects, however FDA maintained that "there's no other drug to help women with a severe lack of sexual desire called hypoactive sexual desire disorder."
