he new pill for female sexual dysfunction may be one of the most talked-about new drugs of the year, but it is not getting off to such a hot start.
After two weeks of availability, a total of 80 prescriptions were filled for Addyi through October 30, according to IMS Health, the market research firm.
Of course, this represents just two weeks of prescribing. Sprout Pharmaceuticals, which was recently purchased by Valeant Pharmaceuticals, began actively marketing its drug only on October 19.
Product launches also often get off to a slow start and Addyi prescriptions may have been further dampened by a key limitation — the drug must be taken every day, but never mixed with alcohol.
Nonetheless, controversy surrounding Addyi generated enormous publicity for the pill, which was the first such medication to be approved by the Food and Drug Administration. The primary issue was debate over whether the FDA would greenlight the pill in response to pressure tactics. To some, the media buzz suggested Addyi might stir substantial interest from women who hoped to jumpstart a low libido.
“I feared there might be a big uptake at the beginning, because it’s the first such drug,” said Cindy Pearson, executive director of the National Women’s Health Network, a nonprofit that argued against FDA approval over safety concerns and limited effectiveness. “I thought if it was accepted rapidly, there would be, perhaps, thousands of prescriptions from the start.”
The controversy over Addyi actually began well before the approval this past summer.
The drug was previously rejected twice by the FDA due to very modest benefits. After Sprout purchased the pill from Boehringer Ingelheim, the drug maker then took a calculated risk. Sprout helped orchestrate a campaign called Even the Score — which was led by some women’s groups — that accused the FDA of bias for having never approved a drug for female sexual dysfunction.
“I thought there would be thousands of prescriptions from the start.”
Cindy Pearson, National Women’s Health Network
Their gripe was that the agency had approved numerous treatments — most notably Viagra — to help men combat impotence. Several lawmakers joined the fray by contacting FDA officials over this concern. This put the agency on the defensive even though there are 21 drugs already approved that contain estrogen to treat pain during sexual intercourse and vaginal dryness associated with menopause.
These problems, however, are not the same as desire. And so, there were dozens of women on hand for an FDA advisory committee last June to publicly implore the committee members to recommend that the agency approve the drug. Sprout, by the way, helped arrange for some of those women to attend the meeting.
The gambit appeared to work. The FDA approved Addyi in August, which set off a sustained round of media coverage. Still, questions remain about the extent to which some women will be willing to avoid alcohol. A small study of 25 people, mostly men, found a few experienced a severe drop in blood pressure when mixing the drug and a few drinks in a short amount of time.
This can cause fainting, so the FDA placed a warning on the Addyi product labeling about this issue. And Sprout devised a so-called risk management program to educate physicians and patients about the risk of drinking and taking Addyi. Such programs are designed to restrict availability and lower the chance that a patient develops a serious side effect.
This helps explain why the prescription rate is low so far. Some of the buzz focused on the risks and the modest benefit. Also, physicians must first complete a questionnaire in order to be certified as a qualified prescriber, although there are only a few questions to answer. Nonetheless, one Wall Street analyst, who asked not to be named, believes these factors may dampen demand indefinitely.
Another factor may be the cost, which is $780 a month, although Sprout offers a patient assistance program that may bring that down to as low as $20.
A spokeswoman for Sprout, meanwhile, noted that the drug maker hired 150 sales reps, but that marketing plans are restricted for the next few months to reaching out only to prescribers. The drug maker agreed not to advertise directly to consumers for the first 18 months. She added that there are also organizational issues under way, since Valent only recently closed the deal to buy Sprout.