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Aquestive Sees Libervant Application Resubmission By End Of Q2

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  • The FDA has provided further guidance to Aquestive Therapeutics Inc (NASDAQ: AQST) regarding the information to be included in the marketing application for Libervant to manage seizure clusters.
  • This guidance FDA addresses the revised weight-based dosing regimen, modeling, and simulation data provided to the Agency in December 2020.
  • The feedback offers direction on the FDA's expectations for the information and supporting analysis relating to the population pharmacokinetic model.
  • The agency also guided its expectations around the nature and format of safety data included in the resubmission.
  • The company plans to resubmit the marketing application around the end of the second quarter of 2021. 
  • Aquestive received a Complete Response Letter from the FDA in September last year citing exposure levels in certain weight groups.
  • Libervant is a buccally (inside of the cheek) administered soluble film formulation of diazepam, a benzodiazepine, for rapid treatment of acute uncontrolled seizures. 
  • Price Action: AQST shares are 3.74% at $5.28 on the last check Thursday.
 

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Posted-In: SeizuresBiotech News FDA General

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