USFDA grants orphan drug status to mexiletine hydrochloride.
- Lupin’s NaMuscula (mexiletine hydrochloride) is the first and only licensed product to treat myotonia in adults with non-dystrophic myotonic (NDM) disorders.
There is a serious unmet medical need for the management of symptoms in patients with myotonic disorders. The decision by the USFDA to grant orphan drug designation to mexiletine brings us closer to providing a licensed treatment option for patients in the US - Lupin CEO Vinita Gupta