The U.S. Food and Drug Administration has corrected 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.
The FDA also said the agency has 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.
Amanda Turney, a press officer for the FDA, contacted The News & Observer following a news release by Sprout to say that pharmacies and practitioners 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.
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. The FDA suggested the new label advise users to stop drinking alcohol two hours before taking Addyi.
The FDA noted in its April release that it ordered the labeling change for Sprout because the agency had not reached an agreement with the company — which had asked for a complete removal of the warning and the contraindication about alcohol.
The FDA determined that removal of that information was not acceptable, then noted 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 contraindication 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.
FDA asked Sprout to take down release
A spokeswoman for Sprout initially declined to comment on why the company deleted its press release from last week — but in a statement released after the online publication of this article, the company said the FDA objected to its information and asked the company to take its release down.
The company’s statement contained a timeline of events, from the FDA’s April label ruling to the removal of its press release earlier this week.
“On September 6th, FDA informed Sprout that it objected to our press release and asked that we take the release down,” the company said. “In an effort to be cooperative, Sprout took its release down early on September 7th.”
The spokeswoman said last week’s 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 because of a successful appeal it had filed in April.
After the FDA’s April ruling that the box warnings and contraindication must stay, Sprout said it immediately appealed the decision to get the warning and contraindication removed.
The company contends that the appeal and a subsequent decision from the FDA gave them leeway to edit Addyi’s labeling — though the company has paused that change as it continues discussions with the FDA.
“The FDA is still working with Addyi to finalize the updated recommendation as it is related to REMS and the alcohol contraindication,” a spokeswoman for Sprout said.
In response to the update from Sprout, the FDA issued only a brief statement:
“FDA was concerned that Sprout’s original press release could lead to confusion among stakeholders, and accordingly we want to clarify that at this time FDA has not approved new labeling for Addyi and has not approved a supplement removing any element of the REMS.”
How is the company faring?
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.
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