Consumer advocates celebrated the little pink pill last year as a milestone for women’s health, a libido fix that promises to trim the gender gap for sexual dysfunction treatments.
But the landmark drug known as Addyi has tallied about 1,000 filled prescriptions in its first two months on the U.S. market, slowed by federal restrictions and limited success in rejuvenating desire, doctors and policy analysts said. Patients in the Pittsburgh area have shown little interest, according to local health systems and insurance companies.
“Women are just smarter than the drug company thought,” said Beth A. Prairie, a midlife-gynecology specialist at West Penn Hospital in Bloomfield. She said the drug has proven “very expensive and not very effective,” dashing women’s early hopes for a magic pill.
The Food and Drug Administration approved Addyi in August as the first prescription treatment meant to enhance sexual desire in women. Raleigh, N.C.-based Sprout Pharmaceuticals overcame two rejections from the FDA to win the clearance, which cracked open a market that could be worth more than $2 billion. Academic estimates suggest 5 million to 9 million women nationwide may face desire disorders.
Addyi targets only premenopausal women with hypoactive sexual desire disorder, or HSDD, a libido-diminishing condition that could affect up to 10 percent of women in the U.S., Sprout has said. The daily pill could help probably fewer than half of them, according to drug researcher and Addyi reviewer Sheryl Kingsberg, who has spoken on behalf of the company.
“I was never expecting — nor should anyone have expected — that women were going to storm the gates for a drug to treat HSDD. This is about women becoming educated” about the condition and its treatments, said Ms. Kingsberg, a division chief in behavioral medicine at MacDonald Women’s Hospital in Cleveland.
She said women with sexual problems often don’t set medical appointments specifically for those issues. Rather, they mention the matter “in the context of another office visit,” a habit that suggests Addyi’s acceptance may take a while, Ms. Kingsberg said.
“I’m not sure that all women are actually aware that there are pharmacologic treatments or any treatment for HSDD that exists,” she said. Company trials found that women on the drug often reported one extra “sexually satisfying event” per month and scored higher on questionnaires gauging desire.
Awareness may not have been such a hurdle for men, more than 500,000 of whom landed Viagra prescriptions in the first month that the erectile-dysfunction drug became available in 1998. Studies suggest around 70 percent of insurance plans include at least partial coverage for ED treatments, while Sprout’s parent company, Valeant Pharmaceuticals, estimated last month that about half of U.S. residents had some coverage for Addyi.
Such uneven insurance polices and stern FDA warnings have helped depress prescription rates, said Sally Greenberg, executive director at the National Consumers League in Washington, D.C. She also blamed “hype in the media” surrounding Addyi’s side effects, along with FDA-imposed rules on medical providers who might offer the drug.
“We know that men are getting covered. There are many choices for men. Now women are running into serious barriers [pursuing] something that did gain FDA approval for safety and effectiveness,” Ms. Greenberg said. “I’m shaking my head and saying, ‘What’s wrong with this picture?’”
The FDA cited safety concerns in setting restrictions on Addyi, which include a written warning that taking the pill with alcohol can lead to dangerously low blood pressure and fainting. The agency also requires pharmacies and physicians to receive special certification before supplying the drug, whose side effects can include nausea and drowsiness.
Valeant said some providers had yet to finish the certification when Addyi became available in October, although it wasn’t clear how many of them were certified. About 6,000 attempted prescriptions had not been filled as of December, illustrating a need for better access, according to the Canadian company.
“There is [a] large unmet need for HSDD, which requires more education about the condition and Addyi as a treatment option,” the company said in a statement. "We will be working on that as a priority moving forward."
Valeant also offers co-pay help for patients on commercial insurance plans and will “work to expand insurance coverage,” according to the company.
Western Pennsylvania health insurers vary in their approaches to the treatment. Downtown-based Highmark Inc. said it includes Addyi on some drug lists; rival UPMC Health Plan said it generally does not. Employers who are self-insured can offer Addyi coverage through both insurers, according to the companies.
For those without any coverage, Highmark said, the price for those without any coverage can reach about $850 each month. Sprout has projected monthly co-pays in the range of $30 to $75.
At the University of Pittsburgh, faculty member Walid F. Gellad said Addyi’s slow start is probably for the best. This way, he said, any unknown dangers from the drug would be more contained.
“There was concern, when the drug was approved, that it should be given only to those people who really need it. My impression is that’s happening because it’s such a small number [of prescriptions] and there are hoops to jump through,” said Dr. Gellad, an associate professor of medicine.
At the nonprofit Consumers League, Ms. Greenberg said she expects competing treatments to join Addyi on the market. Part of a coalition called Even the Score, her group already has “our work cut out” in making sure women have full access, she said.
“Our argument all along has been that we need parity for women and men who need treatment for sexual dysfunction,” Ms. Greenberg said.
Adam Smeltz: firstname.lastname@example.org, 412-263-2625 or on Twitter @asmeltz. Bloomberg News and the Associated Press contributed.