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

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 06 Sep 2023

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At a glance

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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