Lupin is pleased to announce that NaMuscla (mexiletine) has been launched in Germany and the United Kingdom (UK). NaMuscla is approved across the European Union (EU) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. These disorders are a group of rare, inherited neuromuscular conditions in which myotonia, the inability to relax muscles following voluntary contraction, is the most prominent clinical symptom. NaMuscla
reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality of-life and other functional outcomes.
The launch of NaMuscla in Germany and the UK follows the European Commission’s approval of the product on 18 December 2018. NaMuscla, designated an Orphan Drug by the European Medicines Agency (EMA), is the first treatment to be licensed across the EU for the symptomatic treatment of myotonia in adults with NDM disorders. The product will be commercialized in Germany by Hormosan Pharma GmbH, a full subsidiary of Lupin Ltd., and in the UK by Lupin Healthcare (UK) Ltd.
Lupin has ongoing partnering discussions for the commercialization of NaMuscla in European territories outside of Germany and the UK.