FDA issues Complete Response letter for Libervant (diazepam) Buccal Film for seizure clusters
In the letter, the FDA cited that, in a study submitted with the NDA, certain weight groups showed a lower drug exposure level than desired. The manufacturers to provide additional pharmacokinetic data to demonstrate that dose adjustments will obtain the desired exposure levels.
Source:
Biospace Inc.
SPS commentary:
Libervant is a formulation of diazepam on a soluble film that is administered on the inside of the cheek. It is intended for fast treatment of acute uncontrolled seizures in refractory patients with epilepsy on stable anti-epileptic drugs. It is unknown if the manufacturers are intending to submit a market authorisation application for licensing in the EU.