The first pill for low libido in women will go on sale in the U.S. after regulators decided that despite its modest benefit and serious side effects, the drug was worthwhile to address an affliction with no other approved treatments.
The Food and Drug Administration said Tuesday that doctors will have to take a training course to be certified to prescribe Sprout Pharmaceuticals Inc.’s Addyi, which will be available as soon as Oct. 17. And patients must sign a form acknowledging risks that include fainting and extreme sleepiness.
Those precautions apply to a drug that has shown in clinical trials to improve sexual desire in patients only slightly. That means closely held Sprout still will have to persuade doctors to prescribe Addyi and insurers to cover the pill, which must be taken daily and will cost about $350 to $400 a month before insurance coverage. Sprout expects insurers to put the drug in tier 2 or 3 on their formularies with a $30 to $75 copay.
“With any kind of medication you always have to balance the benefit with the risk,” said Holly Thacker, director of the Cleveland Clinic Center for Specialized Women’s Health. “Yes, there are side effects. They’re not life-threatening and they’re not outside the norm of medications in a similar class,” such as neurotransmitters for conditions like depression.
One of the largest U.S. health insurers, Anthem Inc., said Wednesday that Addyi will be a tier 3 drug, though coverage can vary by state and plan. That means patients will pay more for it than for generics and preferred brand-name drugs.
In clinical trials, women who took Addyi recorded a median increase of 0.5 to one more satisfying sexual events each month than those who got a placebo. Women began the trials experiencing two to three satisfying sexual events a month. Some women experienced as many as six to eight more satisfying sexual events each month, Sprout Chief Executive Officer Cindy Whitehead said in a phone interview.
The FDA had previously rejected the drug in 2013 for its modest effect, and then faced a backlash from some doctors and researchers who claimed the agency was being sexist. Drugs to treat male sexual dysfunction have become ubiquitous since Pfizer Inc.’s Viagra was approved in 1998. Viagra generated $1.69 billion in sales last year.
Unlike Viagra, which helps men who want to have sex get an erection by increasing blood flow to the penis, Addyi is designed to alter the brain chemistry of women so they find sex more desirable. The drug targets neurotransmitters such as dopamine and norepinephrine that the brain uses to transmit information and can affect mood. Antidepressant drugs use similar mechanisms.
Addyi, also called flibanserin, is approved for women diagnosed with a condition called hypoactive sexual desire disorder, which is low libido that causes stress. Whitehead said doctors will be able to get certified to prescribe the drug by watching an online video.
Before the FDA ruling on Addyi, some women’s health experts had argued that the drug’s associated risks of fainting and extreme sleepiness outweighed any benefit. Studies found the risks are exacerbated by alcohol and birth-control medicine.
Sprout backed a lobbying campaign called Even the Score to help pressure regulators to approve Addyi, winning the endorsement of groups such as the National Organization for Women and the American Sexual Health Association.
“They have gotten a drug that is barely better than placebo with serious side effects approved,” said Adriane Fugh-Berman, the director of PharmedOut, a Georgetown University Medical Center group that calls for thoughtful use of drugs and looks at industry marketing. “I think that we can expect all kind of creative attacks on the FDA to pressure them to approve bad drugs since that tactic appeared to work.”
Addyi’s label will advise women to stop taking the pill if they don’t respond after eight weeks, Whitehead said.
“This is a transformational moment, hopefully across all of women’s health care, certainly in women’s sexual health,” Whitehead said. “Our breaking through, I hope, opens the door for a variety of treatments to come forward.”
In June, FDA advisers recommended in an 18-6 vote that the FDA approve the drug. While advisers said the pill’s effect isn’t as strong as they’d like, they said they voted in favor to get the first female sexual desire drug on the market and boost awareness to get better treatments on pharmacy shelves in the future.
“That group was looking at a whole lot of scientific evidence,” Whitehead said today in an interview on Bloomberg Television. “Science made this possible.”
About 2 million women are currently seeking treatment for the disorder and more are expected to come forward once Addyi is on the market, said Carl Spana, CEO of Palatin Technologies Inc., which is developing its own female sex-drive treatment.
The company is in the final stages of testing its drug bremelanotide for use as needed, like Viagra, while Addyi is taken every night before bed. Palatin estimates the market for low female sexual desire treatments could total $1.3 billion a year, based on the 2 million women known to be affected.
Palatin shares jumped 28 percent to $1.20 in late trading after Sprout’s approval was announced.
Palatin could bring bremelanotide to market in early 2018, Spana said. The company has had talks with larger drugmakers, which he declined to name, that would likely license bremelanotide for sale.