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A Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral Sclerosis (ALS)

Trial Profile

A Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral Sclerosis (ALS)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 25 Nov 2019

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At a glance

  • Drugs Riluzole (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions
  • Sponsors Aquestive Therapeutics
  • Most Recent Events

    • 25 Nov 2019 According to an Aquestive Therapeutics media release, Exservan (riluzole) Oral Film received early-action approval from the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS). The company received full FDA approval for Exservan in advance to PDUFA action date.
    • 08 May 2019 According to an Aquestive Therapeutics media release, the U.S. Food and Drug Administration (FDA) has accepted NDA for Exservan™ (riluzole) Oral Film. The PDUFA (Prescription Drug User Fee Act) goal date is November 30, 2019.
    • 18 Jan 2019 Status changed from recruiting to discontinued.
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