AQST - FDA responds to Aquestive NDA of cluster seizure drug

Aquestive Therapeutics (AQST) announces that FDA has issued a complete response letter regarding the New Drug Application  for Libervant Buccal Film for management of seizure clusters.FDA cited that, in a study submitted by the company with the NDA, certain weight groups showed a lower drug exposure level than desired.Company intends to provide to the FDA additional information on PK modeling to demonstrate that dose adjustments will obtain the desired exposure levels.CEO reacts: “While we are surprised by and disappointed with the Agency’s decision, we remain committed to continuing to work with the FDA toward approval of Libervant to provide epilepsy patients with the first orally administered treatment for breakthrough and seizure clusters,” said Keith J. Kendall, President and CEO.

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FDA responds to Aquestive NDA of cluster seizure drug