Tolperisone is a novel therapeutic compound that has been shown in clinical studies to be safe and effective in the treatment of significant musculoskeletal conditions, including neuromuscular spasms and spasticity. In addition to being widely evaluated in clinical studies, it is the leading commercial product for these indications in many European countries and Japan. Through wide commercial usage and clinical studies, it has been shown that tolperisone is non-sedating, a key differentiating feature from products that are currently marketed in the US, including cyclobenzaprine.
Tolperisone is a clinical stage product ready to enter Phase 2 clinical trials. The Company has completed a clinical study to confirm the non-sedative properties of tolperisone using a driving simulation study. With the completion of this study, the Company is planning to commence Phase 2 clinical trials, which are expected to be completed within one year. The subsequent Phase 3 clinical program will be a a 2-week trial designed to establish safety and effectiveness in patients with neuromuscular spasms, and is expected to complete within one year. This will serve as the basis for a New Drug Application (NDA) to obtain regulatory approval from the FDA.
New patents for both the process and composition of matter have been issued by the US Patent and Trademark Office (USPTO) providing Orange Book listable patent protection through 2032.