Lupin announced that the European Commission (EC) has approved NaMuscla® (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NOM) disorders. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. NaMuscla® reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional outcomes. The approval was based on a pivotal Phase Ill clinical study (MYOM EX 1) which en rolled 25 participants who were diagnosed with non-dystrophic myotonic disorders and symptomatic myotonia, in addition to bibliographical references, including a randomized, placebo-controlled clinical study and an observational study, to support the efficacy and safety of mexiletine.