AVANIR INITIATES PHASE III CLINICAL TRIAL OF NEURODEX

Avanir has announced the initiation of a double-blind, placebo-controlled, multicenter, Phase III clinical trial of Neurodex in patients with diabetic neuropathic pain.

The randomized, placebo-controlled study will assess efficacy, overall safety and tolerability of Avanir's investigational drug targeting central nervous system receptors to treat diabetic neuropathic pain.

The three-month study will assess the efficacy of Neurodex in relieving pain in adult patients with distal symmetrical diabetic neuropathy with daily pain in the lower extremities. The clinical trial will be conducted at 40 sites in the U.S. and will include assessment scales completed in the clinic and diary records to assess pain. Patients will be randomized to receive placebo or one of two dose levels of Neurodex.

The clinical trial protocol was reviewed by the FDA through a special protocol assessment (SPA) process. An SPA is a binding agreement between the FDA and the sponsor of a clinical trial documenting that if the study endpoints are met, the results should be sufficient to support approval of a New Drug Application (NDA). Avanir expects that this will be the first of two Phase III clinical trials needed to submit an NDA for Neurodex for this indication.