AVANIR RECEIVES SPA FOR NEURODEX NEUROPATHIC PAIN CLINICAL TRIAL

Avanir Pharmaceuticals has announced that the company and the FDA have reached agreement on Avanir's protocol for a Phase III clinical trial of Neurodex in the treatment of painful diabetic neuropathy, a type of chronic neuropathic pain.

The special protocol assessment from the FDA documents agreement on the protocol under which Avanir will conduct and analyze the data from a pivotal trial evaluating the safety and efficacy of Neurodex in the treatment of painful diabetic neuropathy.

Neurodex is comprised of dextromethorphan and an enzyme inhibitor that slows the rapid metabolism of dextromethorphan in the liver. Slowing the metabolism of dextromethorphan with the inhibitor makes it possible to maintain therapeutic levels for a longer period of time. Neurodex has an anti-excitatory effect by reducing glutamate through the combined actions of sigma-1 agonist activity and NMDA receptor antagonism, suggesting utility in treating certain central nervous system disorders, including neuropathic pain.