First-Ever Female Libido Pill Gets Relief on Alcohol Warning

12 Apr 2019, 03:17 AM IST

(Bloomberg) --

The little pink pill designed to help women increase their libido will no longer warn users not to drink alcohol.

The Food and Drug Administration said Thursday that the warning for the treatment, called Addyi, was updated to show that women should discontinue drinking alcohol two hours before taking a pill and shouldn’t resume until the morning after taking it at bedtime.

Sprout Pharmaceuticals Inc., the maker of Addyi, had sought to remove the alcohol warning completely, so this isn’t a total win for the company. The FDA said it couldn’t reach agreement with Sprout and ordered the drugmaker to make the change, which is rare.
Addyi has suffered from weak sales in part because it has to be taken daily and women are supposed to avoid alcohol or risk low blood pressure that can cause fainting.
Studies after the drug hit the market didn’t show any low blood pressure or passing out that required intervention when women on Addyi drank. But the agency said there were missing measurements that raised concerns.
The new label could be a boost to Addyi just as it’s set to possibly face new competition from another drug aiming for FDA approval in June. The injection bremelanotide from Amag Pharmaceuticals Inc. and Palatin Technologies Inc. only needs to be taken as needed in anticipation of sexual activity, instead of daily like Addyi.

Valeant Pharmaceuticals International Inc., now known as Bausch Health Cos., bought Sprout for about $1 billion in cash shortly after Addyi was approved. But the company gave the pill back to Sprout in 2017, ending a lawsuit over alleged bungled marketing of the pill.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Mark Schoifet, Timothy Annett