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A randomized, open-label, two-sequence, two-period, two-treatment crossover study to evaluate the effect of food on the pharmacokinetics of Valtoco in healthy adult subjects

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Trial Profile

A randomized, open-label, two-sequence, two-period, two-treatment crossover study to evaluate the effect of food on the pharmacokinetics of Valtoco in healthy adult subjects

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Sep 2022

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At a glance

  • Drugs Diazepam (Primary)
  • Indications Epilepsy
  • Focus Registrational; Therapeutic Use
  • Sponsors Aquestive Therapeutics

Most Recent Events

  • 02 Sep 2022 New trial record
  • 31 Aug 2022 According to an Aquestive Therapeutics media release, the U.S. Food & Drug Administration (FDA) has granted tentative approval 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 12 years of age and older subject to the expiration of Valtoco orphan drug market exclusivity.
  • 31 Aug 2022 According to an Aquestive Therapeutics media release, results from this study were submitted for the review of Libervant™ (diazepam) Buccal Film FDA approval along with a cross-study comparison to a similar study performed with Libervant.

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