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.
(c)2019 The News & Observer (Raleigh, N.C.)
Visit The News & Observer (Raleigh, N.C.) at www.newsobserver.com
Distributed by Tribune Content Agency, LLC.