Global pharma major Lupin Limited (Lupin) and Exeltis Healthcare (Exeltis) announced that the Spanish Ministry of Health (MSCBC) has approved the reimbursement of Lupin’s NaMuscla (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders on the National Health and Pharmacy Service.

NaMuscla is the first and only licensed product for this indication in Europe and will be commercialized by Lupin’s partner Exeltis in Spain.

NDM disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 100,000 inhabitants in Spain, and are characterized by the inability to relax muscles following voluntary contraction (myotonia). NaMuscla reduces myotonia symptoms in people with NDM, resulting in a significant improvement in quality of life and other functional and clinical outcomes for patients. NaMuscla, which has been designated orphan drug status, received EU marketing authorization in December 2018.

“NDM patients in Spain will now be able to access NaMuscla in a sustainable way. We are grateful to all stakeholders involved in the approval process, especially our partner Exeltis,” said Thierry Volle, President EMEA, Lupin.

“Lupin’s transformational journey into specialty disease areas continues, with future investments planned for neuromuscular diseases, to meet the unmet needs of patients,” added Volle.

"We are excited by this decision which will enable us to provide a new, innovative treatment option that addresses the unmet needs of patients with NDM as soon as possible," said Alberto Fábregas Gil, Director General Spain and Portugal, Exeltis.

"This news allows us to distribute NaMuscla quickly and effectively and strengthen our position in the central nervous system area," added Gil.