Pseudobulbar Affect Trial Exceeds Enrollment Goal

AVANIR Pharmaceuticals today announced that patient enrollment is complete in the Company's second pivotal Phase III clinical trial evaluating Neurodex(TM) for the treatment of pseudobulbar affect (PBA) in patients with neurological disorders. The clinical trial is being conducted in patients suffering from multiple sclerosis (MS) who also have PBA. Results of AVANIR's previous Phase III clinical study of PBA in patients with amyotrophic lateral sclerosis (ALS) were positive, with statistical significance achieved in the primary and all secondary endpoints.

"Due to an increase in interest over the past quarter our clinical trial has exceeded its patient enrollment goal," said Gerald J. Yakatan, Ph.D., President and CEO of AVANIR Pharmaceuticals. "Our clinical and regulatory team has done an outstanding job in enlisting patients while maintaining stringent enrollment standards. Upon completion of the trial, we will unblind and analyze the data and conduct a standard review for completeness and accuracy. Assuming the data are favorable, we expect to submit our new drug application (NDA) this year."

Pseudobulbar affect, a condition also known as emotional lability, affects a diverse population of patients, including those with Alzheimer's, MS, Lou Gehrig's disease or ALS, Parkinson's, and those with neuronal damage following stroke or traumatic brain injury. While the underlying neurological disorders that cause PBA vary from patient to patient, the condition manifests in inappropriate and uncontrollable emotional outbursts. IMS Health estimates the market for PBA to be $450 million by 2005. Currently, there are no approved drugs designated for the treatment of PBA.

A total of 150 patients have been enrolled in the clinical trial, which was originally designed to include 140 patients. Patients in the trial are randomized to receive either Neurodex or placebo for a 3-month treatment period. As in the first Phase III clinical trial, the primary endpoint is the change in a subject's score on the CNS-Lability Scale (CNS-LS) compared to a baseline score prior to treatment. The CNS-LS is a validated, published scale that measures the severity and frequency of a subject's episodes of emotional lability.

The double-blind clinical trial is being conducted at 19 study sites in the U.S. and four sites in Israel. A broader open-label study is also ongoing that involves patients with symptoms of PBA in conjunction with neurological disorders such as stroke, Alzheimer's disease, ALS, MS, and traumatic brain injury.

AVANIR has the exclusive license to develop, manufacture and market Neurodex(TM) for multiple potential indications including pseudobulbar affect, neuropathic pain, chronic cough and weaning drug-dependent patients from narcotics and anti-depressants.