AVANIR ANNOUNCES PUBLICATION OF NEUROPATHIC PAIN STUDY

Avanir Pharmaceuticals announced that results of a Phase II clinical trial evaluating escalating doses of Neurodex in the treatment of painful diabetic neuropathy were published for the first time in the October issue of Clinical Therapeutics. The study, "Dextromethorphan and Quinidine in Adult Patients with Uncontrolled Painful Diabetic Peripheral Neuropathy: A 29-Day, Multicenter, Open-Label, Dose-Escalation Study," indicates that the investigational new drug was well-tolerated up to the highest target dose (60 mg dextromethorphan and 60 mg of quinidine twice a day).

The trial, conducted at five U.S. sites in 36 patients, assessed the safety and tolerability of Neurodex, a proprietary formulation of dextromethorphan, and low-dose quinidine. A preliminary assessment of the drug candidate's efficacy in the treatment of painful diabetic neuropathy was obtained using pain ratings scales and patient diaries. At the end of the study, mean changes from baseline using Pain Intensity Rating Scale and the Pain Relief Rating Scale scores were highly statistically significant. Daily patient diary assessments also demonstrated statistically significant improvements in sleep, present pain intensity, activity and pain rating scales.

Adverse events related to Neurodex were mild to moderate and were consistent with the previously known effects of the drug. Adverse events reported included nausea, dizziness and headache. Three patients did not complete the study, two due to adverse events and one due to inability to comply with the protocol. Ninety-two percent of participants completed the study, and 70 percent of the subjects who completed the study tolerated the maximum allowed dose.