More than a half-million men got prescriptions for Viagra in its first month on the market in 1998. And nearly 2 million men tried Eli Lilly and Co.'s Cialis in its first year on the market after it was launched in 2003.
The number of prescriptions for Addyi, the women’s libido-boosting pill, in its first few weeks? 227.
“I thought there was going to be this huge onslaught,” said Stephanie Faubion, director of the Women’s Health Clinic at the Mayo Clinic in Rochester, Minnesota. “There have been a few casual inquiries, but no prescriptions yet.”
Addyi, made by Valeant Pharmaceuticals International Inc.’s Sprout unit, was controversial even before it hit the U.S. market on Oct. 17. The drug created quite a media buzz leading up to its launch, due to its uniqueness.
The pill offers meaningful help for only about 10 percent more patients than a placebo, and it comes with a risk of serious side effects, including severely low blood pressure and fainting. To minimize these potential problems, women are supposed to refrain from alcohol while taking the daily pill.
“There’s been a lot of skepticism about this particular drug, from both women and their clinicians,” said Alina Salganicoff, vice president and director of women’s health programs at the Kaiser Family Foundation in Menlo Park, California.
The Food and Drug Administration had twice rejected Addyi, approving it Aug. 18 on the condition that doctors get certified to prescribe it, to ensure they understand the risks and can counsel patients about them. This requires online training that takes about 10 minutes to complete. The certification is an additional FDA safeguard to ensure proper use of particularly risky medications.
1 percent certified
Some 5,600 doctors have been cleared so far, said Michael Pearson, Valeant’s chief executive officer, on a Nov. 10 earnings call. That’s about 1 percent of the more than 35,000 practicing obstetricians and gynecologists and 435,084 primary- care physicians in the U.S., based on data from the American Congress of Obstetricians and Gynecologists and the Kaiser foundation.
One hold-up for physicians may be that they must fax in their certification paperwork, said Tami Rowen, an ob/gyn at the University of California San Francisco Medical Center. Doctors should be able to complete the process fully online by the spring, Addyi manufacturer Sprout Pharmaceuticals Inc. said in a statement. Valeant bought Sprout for $1 billion soon after the drug was approved for sale.
Sprout has a sales force of about 150 drug representatives and a managed-care team helping educate doctors and pharmacists about the safe use of the pill, CEO Cindy Whitehead said in an e-mailed statement.
“We are proud that Sprout has been able to launch Addyi just two months after FDA approval, and we are confident in where we stand just a few short weeks after coming to the market,” she wrote.
Addyi is approved for premenopausal women with hypoactive sexual-desire disorder, so a patient’s low libido must be caused by the disorder, not a psychiatric condition or problems within the relationship.
That’s a “relatively small number of women,” said Jonathan Schaffir, an ob/gyn at the Ohio State University Wexner Medical Center in Columbus, who added that none of his patients have asked him about Addyi. He helped run clinical trials for the drug several years ago when it was still owned by Boehringer Ingelheim GmbH.
The restriction on alcohol seems to be a deterrent for women who do ask about it.
“You want to have the option to have a glass of wine,” said Rowen, the San Francisco doctor.
Sprout had pledged it wouldn’t advertise directly to consumers for 18 months, but Whitehead said shortly after Addyi was approved that this could change under Valeant.
Valeant is under fire for price increases on older drugs and a now-terminated relationship with a mail-order pharmacy, Philidor Rx Services, that helped boost insurer reimbursement. Valeant declined to comment on whether Philidor, which is closing down, had an agreement to fill Addyi prescriptions. The pharmacy has said it filled scripts only with medicine that doctors and patients requested.
Not like Viagra
Women may be discouraged to learn that Addyi doesn’t work like sexual-dysfunction pills for men.
“It’s not like Viagra, where you pop it and you get the outcome,” said Pepper Schwartz, a professor of sociology at the University of Washington in Seattle who studies sexuality and relationships. “You have to build it up over time.”
Drugs like Pfizer Inc.’s Viagra and Lilly's Cialis, which had combined sales of $3.98 billion last year, help men who can’t get an erection by increasing blood flow to the penis. Addyi is similar to an antidepressant, targeting neurotransmitters such as dopamine and norepinephrine that communicate information throughout the mind and body and can affect mood.
Prescriptions for Viagra totaled 598,452 between March 27, 1998, when it was approved, and the end of April 1998, based on data from IMS Health. Addyi prescriptions totaled 227 from Oct. 17, when it became available to the public, through Nov. 6, according to Bloomberg Intelligence data. Pfizer didn’t directly advertise to consumers in the first month Viagra was on the market, company spokesman Steven Danehy said.
Cost may be an issue with Addyi. Sprout wouldn’t provide a price, but the pharmacy at the Rochester Women’s Health Clinic sells it for $26 a pill, Faubion said. That’s about the cost of Viagra, yet Addyi must be taken every day, so the monthly tally is about $780.
Insurers and pharmacy-benefit managers have said they either aren’t covering Addyi or are placing it on their third tier, meaning it will cost patients more than generic medications or preferred brand-name treatments. Insurers often don’t cover so-called lifestyle drugs. Sprout has said it has an assistance program that will help women get Addyi for $20 a month.
“I had a hunch that it might not be a blockbuster," said Thea Cacchioni, a sociologist at the University of Victoria in British Columbia who recently published a book, “Big Pharma, Women and the Labour of Love.”
In fact, it’s worth scrutinizing the whole idea that low sexual desire is a problem, she said, because it takes away from the variety of human sexuality.
“It’s a really recent idea that we should have a high sex desire all the time,” said Cacchioni, who testified against approval of Addyi before the FDA in 2010 and this year. “We now feel a lot of pressure if we don’t meet the kind of hypersexuality we see in the media.” In reality, she says, “desire is too abstract to measure.”