CHMP recommends approval of Namuscla in myotonic disorders.- Lupin.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Namuscla (mexiletine), from Lupin, intended for the treatment of myotoniain adults with certain hereditary muscle disorders. Namuscla will be available as capsules (167 mg).
The benefits with Namuscla are its ability to reduce muscle stiffness and improve quality of life in patients with non-dystrophic myotonic disorders (sodium or chloride channelopathies). The most common side effects are abdominal pain, vertigo and insomnia; arrhythmias and DRESS (drug reaction with eosinophilia and systemic symptoms) may occur. The full indication is: �symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.�
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