SAN DIEGO, Dec. 20 /PRNewswire/ -- Avanir Pharmaceuticals (Amex: AVN), today announced the initiation of a Phase II/III clinical trial of its drug candidate, AVP-923. This clinical trial is the first in a series of studies intended to examine the effect of AVP-923 in the treatment of emotional lability in neurodegenerative diseases.
Approximately 100 patients with Lou Gehrig's disease (Amyotrophic Lateral Sclerosis or ALS) are participating in the initial clinical trial. Pending positive results from the clinical trial in ALS patients, Avanir plans to initiate a second clinical trial that will be conducted in multiple sclerosis (MS) patients in 2001. An open-label study will follow the MS trial that will enroll patients with symptoms of emotional lability occurring in any of the following conditions: stroke, Alzheimer's disease, ALS, and MS.
"We have designed these studies to be comprehensive and geographically diverse so that they can be used as pivotal clinical trials for filing a new drug application," said Gerald J. Yakatan, Ph.D., president and chief executive officer of Avanir Pharmaceuticals. "The investigators participating in the trial are all recognized experts in treating ALS patients."
The double-blind, controlled, multicenter study is being monitored by INC Research, a contract research organization that specializes in clinical trials related to disorders of the central nervous system. INC Research will also perform the data management and statistical analysis portions of the study. Enrollment in the Phase II/III trial is anticipated to continue through July of 2001 in 11 clinics across the country.
Combined affected patient populations result in a patient pool up to 1,000,000 patients per year. Currently, there is no FDA-approved product available that is indicated for the treatment of emotional lability in patients who suffer from this condition.
Avanir Pharmaceuticals, based in San Diego, is engaged in research, development, commercialization, licensing and sales of innovative drug products and antibody generation services. The company's website is http://www.avanir.com.
The information contained
in this press release, including any forward-looking statements contained
herein, should be reviewed in conjunction with the company's Annual Report
on Form 10-K and other publicly available information regarding the company.
Copies of such information are available from the company upon request.
Such publicly available information sets forth many risks and uncertainties
related to the company's business and technology. Forward-looking statements
often contain such words like "estimate," "anticipate," "believe," "plan"
or "expect." Preliminary research findings are not always supportable
by evidence obtained from subsequent clinical trials. Final review
decisions made by the FDA and other regulatory agencies concerning clinical
trials results for AVP-923 are unpredictable and outside of the influence
and/or control of the company.
SOURCE Avanir Pharmaceuticals
Web Site: http://www.avanir.com