NaMuscla® is an antimyotonic agent which is approved by the European Medicines Agency to treat symptomatic myotonia in adults with non-dystrophic myotonic disorders. In randomized controlled trials, NaMuscla® (mexiletine 167 to 500 mg/day 1 ) has been shown to significantly reduce myotonia compared to placebo, restoring skeletal muscle hyperexcitability through its use-dependent, voltage-gated, sodium channel blocking actions which are independent of the cause of channel dysfunction. This resulted in an improvement in patient quality-of-life and other functional outcomes, with gastro-intestinal discomfort reported as the most common adverse event, demonstrating NaMuscla® to be safe and well tolerated. 2,3
The marketing authorization holder for NaMuscla® in EU is Lupin Europe GmbH.
1. Clinical Study Report refers to 200 mg dose which is the amount of mexiletine hydrochloride (corresponding to 166.62mg mexiletine base)
2. NaMuscla® Summary of Product Characteristics, Assistance Publique – Hopitaux de Paris (AP-HP) sponsor of MYOMEX
3. Trivedi et al. 2013
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