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TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents.

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Trial Profile

TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2023

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At a glance

  • Drugs Naproxen sodium/sumatriptan (Primary)
  • Indications Migraine with aura; Migraine without aura
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 15 May 2015 According to a Pernix Therapeutics Holdings media release, the U.S. FDA has approved Treximet for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.
    • 01 May 2015 According to a Pernix Therapeutics Holdings media release, Treximet was granted pediatric exclusivity by the FDA, which will extend U.S. market exclusivity associated with the Orange Book listing for Treximet s patents by an additional six months.
    • 01 May 2015 According to a Pernix Therapeutics Holdings media release, sNDA for Treximet for use in adolescent patients for acute treatment of migraine has been accepted for filing with priority review; FDA action is expected by May 14, 2015.
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