The United States has the opportuntiy to benefit
a treatment that has provided relief for millions in parts of Europe and Asia.
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,
Broad Nervous System Coverage
Inhibition of spinal reflexes via presynaptic blockade of both voltage-gated calcium channels and voltage-gated sodium channels
Reversible blockade of voltage-gated sodium and calcium channels
Dual mechanism of sodium and calcium channel blockade may provide effective analgesic activity in addition to muscle relaxation
No binding activity directed to the benzodiazepine receptor
No opioid binding activity; no abuse potential