FDA delivers setback to Aquestive Therapeutics

Sept. 29, 2020

The FDA has sent a complete response letter to Aquestive Therapeutics for a seizure medication delivered on an oral film.

The medication, Libervant, had been set to become Aquestive’s second commercially approved treatment for patients with epilepsy. But the FDA’s CRL took issue with the exposure level to Libervant, a buccal film formulation of diazepam, in patients from differing weight groups.

The FDA also had concerns about protocol deviations in blood draws from one of the studies.

Aquestive reported that there were no regulatory concerns around safety or manufacturing, and that it will not have to conduct any additional studies for the FDA. Instead, the company is planning to give the FDA more information and then refile for approval before the end of the year. 

Aquestive specializes in reformulating existing drugs for oral delivery technologies to offer an alternative to patients who might struggle with the challenges of taking daily medication, such as trouble swallowing pills.

Read the press release.