The Food and Drug Administration on Tuesday approved Raleigh-based Sprout Pharmaceuticals’ drug Addyi – the world’s first pill to boost women’s sex drive.
The decision comes after months of debate between supporters and critics of the controversial drug and gives Sprout a potential blockbuster that could earn the company hundreds of millions of dollars.
“It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life-impacting condition,” Cindy Whitehead, Sprout’s CEO, said in a statement. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”
The FDA had rejected the drug twice in the past five years because of questions about its safety and effectiveness. In clinical trials, the drug showed a modest – though statistically significant – change in sexual desire.
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In approving the drug, the FDA said it can cause low blood pressure and loss of consciousness, and that these risks are increased and more severe when patients drink alcohol.
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health professionals and certified pharmacies,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
Addyi will come with warnings highlighting the risks in patients who drink alcohol, and the agency is requiring Sprout to conduct three studies in women to better understand the risks of the interaction between the drug and alcohol.
In recent months the FDA was the target of a media offensive by advocates who accused the agency of gender bias and paternalism. An FDA advisory panel in June recommended the agency reverse course and approve the drug.
Sprout’s drug can be prescribed to pre-menopausal women with a medical diagnosis, based on a questionnaire and defined by low sex drive and accompanying distress. Unlike Viagra, which increases blood flow for men, Addyi influences brain chemistry. It has to be taken every day and could take several weeks to become effective.
The company estimates 3 out of 10 women in this country have low sex drive, but only 1 out of 10 has the condition accompanied by distress, a potential U.S. market of about 16 million women.
Sprout, which has 31 employees, expects to “quadruple in size” by hiring drug sales reps to promote the pill to doctors who would prescribe it, Whitehead said in a recent interview. The company plans to ramp up production quickly at facilities in Virginia and Georgia so it can get the pills to patients this year. Sprout has promised the FDA it won’t advertise the drug for 18 months on TV and radio.
The company expects an Addyi (pronounced “addie”) prescription will cost between $30 and $75 a month for women who have health insurance, with the insurer covering the rest, based on policies that cover Viagra.
Sprout also plans to reduce patients’ out-of-pocket costs with a copay assistance program when the drug is launched.
The German company Boehringer Ingelheim initially developed flibanserin, the active drug in Addyi, as an anti-depressant but switched it to a sex drive treatment when patients in clinical trials began reporting improved sexual desire.
When the FDA rejected flibanserin in 2010, Boehringer Ingelheim put the drug up for sale. Slate, a Durham company run by pharmaceutical executives Cindy and Bob Whitehead, acquired the rights.
The couple renamed the company Sprout in 2011 and moved it to Raleigh. Sprout has raised $100 million from more than 100 private investors.