Regulatory Focus™ > News Articles > 2019 > 9 > FDA Tells Company to Pull Press Release on Drinking With Female Libido Drug

FDA Tells Company to Pull Press Release on Drinking With Female Libido Drug

Posted 13 September 2019 | By Zachary Brennan 

FDA Tells Company to Pull Press Release on Drinking With Female Libido Drug

Last April, Sprout Pharmaceuticals completed postmarketing trials for its drug Addyi (flibanserin), which is used to treat decreased sexual desire in women, and the US Food and Drug Administration (FDA) said it could change the labeling of the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely.

FDA’s decision on the label followed a push from Sprout to remove the warning entirely. Sprout touted newly released safety data, purportedly showing how Addyi and alcohol interactions “resulted in no increased incidence of adverse events of special interest.”

But FDA also said that in at least one study for the previously twice-rejected drug, there was data missing, and the “proportion of missing data increased with increasing alcohol dose. Furthermore, the peak time for the missing data occurred between one and four hours after taking Addyi and alcohol, which is the time when Addyi achieves maximum blood concentrations; this observation further supports the Addyi-alcohol interaction.”

Within 11 days of that April FDA announcement, Sprout said it completed all the required paperwork to modify Addyi’s labeling and risk evaluation and mitigation strategies (REMS). The company then issued a press release on 4 September, two weeks after it received FDA’s Office of New Drugs (OND) final decision letter.
But then on 6 September, FDA informed Sprout that it objected to its press release and asked that it be taken down, the company said.

“In an effort to be cooperative, Sprout took its release down early on September 7th. Starting September 10th, FDA began alerting media outlets that ‘at this time’ FDA has not made these changes,” Sprout said in a news release on 11 September.

Sprout also claimed that Peter Stein, director of FDA’s Office of New Drugs, said in August: “My assessment is that the new information narrows the risk of the flibanserin-alcohol interaction and that a [boxed warning] and a verifiably comprehensible medication guide should provide appropriate management of the risk. Based upon this, a REMS that includes a medication guide, but not ETASU, is appropriate to ensure that the benefits outweigh the risks.”

Regarding the contraindication, according to Sprout, Stein also said, “The labeling should, therefore, be revised so that the [contraindication] is limited to women on moderate or strong CYP3A4 inhibitors or who have hepatic impairment, populations for whom the benefit of treatment do not outweigh its risks. The Company can submit a proposed revised labeling that removes the contraindication for use of alcohol with flibanserin.”

A spokesperson for Sprout did not offer any updates on the situation, although Sprout CEO Cindy Eckert told a Raleigh-based TV station on Thursday that FDA should dictate what happens next.

“The FDA has had our new alcohol studies that are the basis of these changes for 400 days,” Eckert told the station. “We anxiously await implementation consistent with their statements.”

FDA did not respond to a request for comment.

Tags: Addyi, FDA, Sprout

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