Doctors will have to take a training course to be certified to prescribe Addyi, and patients will need to sign a form saying they understand the risks, which will also be featured prominently on the label.
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In approving the drug Tuesday, the FDA acknowledged it had continuing concerns about Addyi’s safety.
“This is really a milestone moment to celebrate”, Whitehead said.
But safety restrictions on the daily pill mean it will probably never achieve the blockbuster sales of men’s impotence drugs like Viagra, which have generated billions of dollars.
While sometimes referred to as sexaminer.com/viagra-like-drug-approved-in-us-to-help-women-with-libido”>the “female Viagra,” the drug is notably different from Viagra, which targets erectile dysfunction, a physiological problem. It must be taken daily, unlike Viagra which is taken only hours before sex. Panelists expressed concerns about potential side effects such as low blood pressure, fatigue and fainting, and questioned data on how the drug may interact with alcohol or birth control pills. The FDA concluded there was a “statistically significant” improvement over a placebo. HSDD is associated with low libido and a sudden loss of sexual desire. Counselors say it is also the most hard to treat.
“This is the biggest breakthrough for women’s sexual health since the pill”, Sally Greenberg, executive director of the National Consumers League, told The New York Times.
“If you have a broken leg, a broken toe or a broken libido, you can now go to a doctor and get help”, he says.
Dr. Susan Wood, a former FDA official now at George Washington University, said she was disappointed by the approval. Sprout will assist patients with co-payments, she said.
Flibanserin (not pictured) has been criticised as having marginal effects.
Opponents, including sex therapist Leonore Tiefer, who was behind a petition calling on the FDA to again reject the drug, said the agency was pressured into approving the pill in a lobbying campaign by pharmaceutical makers. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi. More than half of pre-menopausal women drink regularly, he said, citing testimony at the June hearing, and 30 percent report binge drinking. For now, it looks like Addyi may get its FDA blessing (after two previous failed attempts) as soon as Tuesday (UPDATED ABOVE), though Sprout has agreed to hold off on television advertising for 18 months after its initial approval. Libido naturally drops with age as hormone levels fall. Hanno is one of the FDA advisers who voted against recommending approval of Addyi last June. “It’s going to be more trouble than it’s worth”, she said.
The effectiveness of the 100 mg bedtime dose of Addyi was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. Many women testified they had lost interest in sex and experienced difficulties in relationships as a result.
“It brought me back to where I was”. She said it worked to alter brain chemicals in those who have HSDD and returns their desire to normal. “For decades, millions of women have been waiting for a medical solution to restore their sexual desire”. “It literally changed overnight”, she said. Sprout has promised the FDA it won’t advertise the drug for 18 months on TV and radio.
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What may have influenced the panel was the company’s “Even the Score” campaign, since no new tests were performed since the most recent rejection in 2013.
