Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents.

Trial Profile

Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 May 2017

At a glance

  • Drugs Naproxen sodium/sumatriptan (Primary)
  • Indications Migraine with aura; Migraine without aura
  • Focus Adverse reactions; Registrational
  • Sponsors GlaxoSmithKline; POZEN
  • Most Recent Events

    • 20 Apr 2015 Included in the sNDA filing were safety and efficacy data sets from this trial and two others conducted to evaluate the pharmacokinetic, efficacy, and long-term safety of Treximet for the acute treatment of adolescent migraine; the company expects approval for Treximet in adolescent patients in the second quarter of 2015, according to a Pernix media release.
    • 25 Feb 2015 According to a Pernix Therapeutics Holdings media release, sNDA for Treximet for use in adolescent patients for acute treatment of migraine has been submitted.
    • 09 Feb 2010 Actual patient number (656) added as reported by ClinicalTrials.gov.
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