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Cindy Eckert, Sprout Pharmaceuticals CEO attends the Inc. Founders House on March 10, 2019 in Austin, Texas. The FDA is refuting recent claims by Sprout Pharmaceuticals that its drug Addyi no longer requires health care practitioners or pharmacies to be certified by the FDA to prescribe or dispense the pill.

Cindy Eckert, Sprout Pharmaceuticals CEO attends the Inc. Founders House on March 10, 2019 in Austin, Texas. The FDA is refuting recent claims by Sprout Pharmaceuticals that its drug Addyi no longer requires health care practitioners or pharmacies to be certified by the FDA to prescribe or dispense the pill. (Rick Kern/Getty Images for Inc/TNS)

RALEIGH, N.C. - The U.S. Food and Drug Administration is refuting recent claims by Raleigh-based Sprout Pharmaceuticals that its drug, the female libido pill Addyi, no longer requires health care practitioners or pharmacies to be certified by the FDA to prescribe or dispense the pill.

Amanda Turney, a press officer for the FDA, reached out to The News & Observer following a news release by Sprout to say that pharmacies and practicitioners still need to be certified under the Risk Evaluation and Mitigation Strategy (REMS) program to prescribe Addyi, which treats hypoactive sexual desire disorder in women.

Last week, Sprout had celebrated in a release to the media that the requirement had been eliminated. Sprout CEO Cindy Eckert told the N&O that the move would likely lead to a boost in sales and that the company would increase its marketing budget for the drug.

But that press release has now been deleted from the company website and from third-party websites that had circulated it.

The FDA spokesperson also noted that the agency had not eliminated its warnings about using alcohol with the drug. The FDA noted that alcohol use with the pill can cause an increased risk of fainting. Because of that, it has required a label warning against drinking alcohol while using Addyi.

In April, the FDA determined that changes should be made to Addyi's labeling to clarify that while there is still a concern about consuming alcohol and taking Addyi, it no longer suggested that alcohol should be completely avoided. It now suggests stopping alcohol intake two hours before taking Addyi.

The FDA noted in its April release that it ordered the labeling change for Sprout because it had not reached an agreement with the company - which had asked for a removal of the warning and the contraindication about alcohol. The FDA determined that removal of that information was not acceptable, then added that it is rare that the agency doesn't reach an agreement with a company.

In its release last week, Sprout said it no longer needed the warning or contradiction on the labeling. On its website, there is still a link to a label without the REMS requirement or the contraindication.

Eckert, who previously went by the last name Whitehead, was not available for comment about the FDA's response. A spokeswoman for Sprout declined to comment on why the company deleted its press release from last week.

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The spokeswoman said the press release was still accurate in regard to its claims around the FDA's softening of its stance about alcohol use, but that the company is still in conversation with the agency about the REMS and contradindication section.

The spokeswoman added that, as the company understood its communications with the FDA, the REMS condition was being dropped.

"The FDA is still working with Addyi to finalize the updated recommendation as it is related to REMS and the alcohol contraindication," the spokeswoman for Sprout said.

The news comes as Sprout works to turn around the fortunes of Addyi, which was the world's first pill to boost women's sex drive.

After originally selling the drug to Valeant Pharmaceuticals in 2015, Addyi never really got off the ground with consumers. After Valeant got into legal troubles, the company gave the drug back to Sprout, which has now started to market it on its own.

Eckert told the N&O last week that the number of women using Addyi has increased every quarter since it bought the drug back from Valeant Pharmaceuticals in 2017.

Addyi also has more competition now, as the FDA approved a competing drug earlier this summer.

Visit The News & Observer (Raleigh, N.C.) at www.newsobserver.com

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