Apr 11, 2002
PR Newswire - USA
AVANIR Pharmaceuticals today announced that enrollment has been completed in a Phase II/III clinical trial of Neurodex in the treatment of emotional lability. The objectives of the trial are to examine the safety and effectiveness of Neurodex in treating pseudobulbar affect, also known as emotional lability or pathological laughing or crying, a symptom experienced by an estimated one million patients with neurological conditions such as Lou Gehrig's disease, Alzheimer's, multiple sclerosis, stroke and traumatic brain injury. Neurodex is the first drug product specifically targeted to the treatment of emotional lability.
"Completion of enrollment in this Neurodex clinical trial is an important milestone in the development of this unique product to treat emotional lability," said AVANIR President and Chief Executive Officer Gerald J. Yakatan, Ph.D. "We anticipate obtaining final data and releasing the results of this study in about three months."
Neurodex is a patented, orally administered combination of dextromethorphan (DM) and an enzyme inhibitor that sustains elevated levels of DM in the human body and allows for a twelve-hour dosing schedule. AVANIR has the exclusive license to develop, manufacture and market Neurodex for four potential indications: emotional lability, neuropathic pain, chronic cough and weaning drug -dependent patients from narcotics and anti-depressants. AVANIR is currently in clinical development with the first two indications. Neurodex is protected by six issued U.S. patents.
Medical journals report that emotional lability occurs in up to 50% of Lou Gehrig's disease (Amyotrophic Lateral Sclerosis or ALS) patients, and 25% of multiple sclerosis (MS) and Alzheimer's disease patients. AVANIR estimates the addressable market for emotional lability to be approximately one million patients in the United States.
AVANIR's current clinical study involves approximately 100 ALS patients who also have the symptoms of emotional lability. The study is a double- blind, controlled, multi-center study conducted at 18 study sites in the U.S. If this clinical trial yields positive results, AVANIR plans to initiate a pivotal Phase III trial that will be conducted in MS patients in 2002. An open-label safety study will follow the MS trial that will include patients with symptoms of emotional lability occurring in stroke, Alzheimer's disease, ALS or MS.
AVANIR Pharmaceuticals, based in San Diego, is a diversified biopharmaceutical company with an FDA-approved product. AVANIR is engaged in research, development, commercialization, licensing and sales of innovative drug products and antibody generation services.
AVANIR press releases and presentations, including any forward-looking statements contained therein, 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," "intend," "plan" or "expect." 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 trial results are unpredictable and outside the influence and/or control of the company.
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