Tolperisone is a medicine widely prescribed outside of the U.S. for acute muscle spasms and spasticity. In the U.S., tolperisone is being investigated as a novel, non-opioid, non-sedating, non-drowsy muscle relaxant for the relief of pain due to muscle spasm. Tolperisone is predicted to have analgesic activity in addition to muscle relaxation because of its centrally-acting dual voltage gated calcium and sodium channel blocker mechanism of action.
Neurana has completed a Phase 1 clinical study which confirmed the non-sedative properties of tolperisone using a driving simulation study. Currently, Neurana has initiated a Phase 2 dose-ranging clinical study, the “STAR Study”, to further demonstrate the safety and efficacy of tolperisone in subjects with acute, painful muscle spasms of the back. Top line data from the Phase 2 “STAR” Study is anticipated in Q3 2019.
Composition of matter and process patents have been issued by the US Patent and Trademark Office (USPTO) providing Orange Book listable patent protection through 2032.
Click to learn more about the STAR Study,