After three failed attempts, the libido-boosting drug flibanserin for women finally passed FDA scrutiny on Tuesday to become the first government-approved treatment for the most prevalent sexual disorder affecting women - a lack of sexual desire.
Some 10 percent of U.S. women, roughly 16 million people, suffer from the problem known as “hypoactive sexual desire disorder” and Dr. Sheryl Kingsberg, a clinical psychologist, has seen the distress it can cause.
“I treat hypoactive sexual desire disorder and I have women who are literally in tears in my office saying, ‘why is there nothing for me?,’ ” said Kingsberg, division chief of behavioral medicine at University Hospitals Case Medical Center in Cleveland, Ohio.
When the little pink pills hit the market later this year under the name “Addyi,” flibanserin will provide relief for millions of pre-menopausal women, helping to improve their lives, relationships and marriages.
By acting on the central nervous system in the brain, Addyi, by Sprout Pharmaceuticals of Raleigh, N.C., will spur the production of dopamine and norepinephrine, neurotransmitters that regulate mood, behavior and sexual excitement.
For women whose low sexual desire isn’t the result of relationship problems, a history of abuse, depression, medical ailments, medication side effects or other non-biologic factors, flibanserin will help restore their sexual appetite.
The drug is also known as the “pink Viagra” should be taken once daily at bedtime to cut the risk of adverse events. Patients who don’t see improvement after eight weeks should discontinue treatment.
“It’s not for everybody,” said Dr. Lisa Larkin, director of the women’s health center at the University of Cincinnati. “Not all women who have low desire have a biologic basis. We understand that very clearly. But there’s a subgroup of patients where biology really is the issue and it’s that group of patients who will be candidates for this medication.”
Addyi can cause a severe drop in blood pressure and a loss of consciousness, risks that increase when taken with alcohol and other medications that impede the drug’s breakdown in the body.
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
While the FDA has approved numerous treatments for sexual dysfunction in men, the agency has been accused of gender bias for failing to approve any such medications for females. Previous candidates - including flibanserin - have been rejected because of a lack of effectiveness and safety concerns. But critics say numerous medications that treat male sexual dysfunction have side effects that are far more dangerous than those posed by Addyi.
“Women have been really suffering in silence with really no treatment options,” Larkin said. “We really just have not given women’s sexual health the same interest and enthusiasm and I think the approval of this drug will really help in that regard.”
Larkin is co-scientific chair of a coalition of flibanserin supporters called “Even the Score,” which is made up of health professionals, trade groups and others.