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Efficacy and Safety of Mexiletine in Non-dystrophic Myotonias

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Trial Profile

Efficacy and Safety of Mexiletine in Non-dystrophic Myotonias

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2019

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At a glance

  • Drugs Mexiletine (Primary)
  • Indications Myotonia; Myotonic disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms MYOMEX

Most Recent Events

  • 07 Jan 2019 According to a Lupin media release, based on the data from this and other studies (randomized, placebo-controlled clinical study and an observational study), the European Commission has approved NaMuscla(mexiletine hydrochloride) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic disorders. The approval will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein.
  • 30 Oct 2018 New trial record
  • 19 Oct 2018 According to a Lupin media release, based on the data from this and other three controlled clinical studies the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of NaMuscla (mexiletine hydrochloride) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders.

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