Corrected: FDA requirements on Raleigh company’s female libido pill for use with alcohol

Editor’s note: On Sept. 11, 2019, after the publication of this article, the U.S. Food and Drug Administration contacted The News & Observer to correct some of the claims made by Sprout Pharmaceuticals. This article has been corrected and updated. Please read our new article about the FDA’s response.

Sprout Pharmaceuticals, the Raleigh maker of the world’s first pill to boost women’s sex drive, sent a press release to news organizations this week that cheered a decision this week by the U.S. Food and Drug Administration to remove a ban on alcohol use with its drug.

It’s a move the company believes could allow it to reintroduce the drug to a wider market than before.

However, the FDA has notified news organizations that the press release is wrong. FDA rules still require Sprout to include a warning on its drug, Addyi, which treats hypoactive sexual desire disorder, noting that alcohol use with the pill causes an increased risk of fainting.

The FDA also still requires health care practitioners or pharmacies to be certified to prescribe or dispense Addyi.

The FDA approved a competing drug earlier this summer.

Cindy Eckert, Sprout’s CEO, said the number of women using Addyi has increased every quarter since it bought the drug back from Valeant Pharmaceuticals in 2017.

Valeant had acquired Sprout in 2015 for $1 billion, soon after Sprout received FDA approval for Addyi, The News & Observer previously reported. The drug was initially expected to sell for between $350 and $400 a month before insurance coverage kicked in. But Valeant ended up charging $800 for a 30-day supply of the pills, and some insurers limited coverage of the drug.

“It’s my experience that much of what has historically been written related to women having their own treatments for sexual desire is a whole lot of opinion and much less evidence based discussion on the data and science,” she said. “But this condition is common and it is treatable. What’s next is a new era of women having true access to treatment in the way that men have had for decades.”

This story was produced with financial support from a coalition of partners led by Innovate Raleigh as part of an independent journalism fellowship program. The N&O maintains full editorial control of the work. Learn more; go to bit.ly/newsinnovate

This story was originally published September 6, 2019 at 7:00 AM.