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Randomized, Open-Label, 2-Way Crossover, 3-Period Study to Evaluate Single Doses of Diazepam Buccal Film Compared With Diazepam Rectal Gel in Adult Males and Females on Concomitant Antiepileptic Drugs for the Treatment of Epilepsy

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Randomized, Open-Label, 2-Way Crossover, 3-Period Study to Evaluate Single Doses of Diazepam Buccal Film Compared With Diazepam Rectal Gel in Adult Males and Females on Concomitant Antiepileptic Drugs for the Treatment of Epilepsy

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 03 May 2024

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At a glance

  • Drugs Diazepam (Primary) ; Diazepam
  • Indications Epilepsy; Seizures
  • Focus Pharmacokinetics; Registrational
  • Sponsors Aquestive Therapeutics

    • Most Recent Events

    • 29 Apr 2024 According to an Aquestive Therapeutics media release, the company receives U.S. Food and Drug Administration (F DA) approval and market access for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy between 2 to 5 years of age.
    • 11 Sep 2023 According to an Aquestive Therapeutics media release, company receives acceptance by the U.S. Food and Drug Administration (FDA) for Libervant (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024. The NDA submitted for Libervant for epilepsy patients between two and five years of age is subject to FDA approval, including for U.S. market access.
    • 29 Jun 2023 According to an Aquestive Therapeutics media release, Libervant™ (diazepam) is currently under an orphan drug block to market access until January 2027. The Company expects to hear from the FDA on the acceptance of, and issuance of a target action date on, this pediatric NDA within approximately two months.

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