RALEIGH – The U.S. Food and Drug Administration says its discussions with Raleigh-based Sprout Pharmaceuticals about its female sexual dysfunction drug Addyi are intended to avoid “confusion” about any changes in warnings regarding the drug’s use.
“The 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,” says Amanda Turney, a spokesperson for the FDA.
REMS refers to “Risk Evaluation and Mitigation Strategy.”
Turney was responding to a request from WRAL TechWire seeking further information regarding an earlier email that FDA sent earlier this week following publication of a story last week in which Sprout said the FDA had made changes regarding use of alcohol with Addyi.
“I wanted to let you know that at this time, the FDA has not revised its warnings about the use of alcohol with Addyi nor has it changed the drug’s Risk Evaluation and Mitigation Strategy (REMS),” Turney, an FDA press officer, wrote.
Sprout CEO Cindy Eckert said the company is working with the FDA to try to resolve the issue. Sprout also issued a timeline of the back-and-forth with the FDA that it says supports the company’s view.
“The story is definitely getting misreported,” Eckert told WRAL TechWire. “We remain very excited about where we’re headed with Addyi.”
Referring to the timeline, Eckert added: “Hopefully this puts the confusion to bed.”
The timeline is included in this story published Wednesday:
FDA, Sprout Pharmaceuticals tangle again over ‘female Viagra’ drug restrictions
