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A phase 3 study of efficacy of diazepam nasal spray in Japanese patients for the treatment of status epilepticus or epileptic seizures

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Trial Profile

A phase 3 study of efficacy of diazepam nasal spray in Japanese patients for the treatment of status epilepticus or epileptic seizures

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Oct 2023

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At a glance

  • Drugs Diazepam (Primary)
  • Indications Epilepsy
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 20 Oct 2023 New trial record
  • 18 Oct 2023 According to an Aculys Pharma media release, company plans to present the results of this interim analysis at an upcoming Japanese medical conference.
  • 18 Oct 2023 According to an Aculys Pharma media release, based on the data obtained from the interim analysis of the Phase 3 clinical trial, Aculys Pharma intends to submit a New Drug Application for diazepam nasal spray as the first intranasally administered antiepileptic drug in Japan to meet the urgent treatment needs of patients with recurrent epileptic seizures.

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