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AVANIR Pharmaceuticals In-Licenses Drug Product To Treat Central Nervous System Disorders
Phase II/III Clinical Trial to Begin in Fall 2000 SAN DIEGO, Aug. 9 /PRNewswire/ -- AVANIR Pharmaceuticals (Amex: AVN), today announced completion of a license agreement for exclusive worldwide rights to a proprietary drug product for the treatment of multiple central nervous system disorders including emotional lability, neuropathic pain and chronic cough. The product was licensed from Irisys Research and Development, a private San Diego contract research organization.
An Investigational New Drug (IND) application for the licensed product, a new formulation of dextromethorphan internally designated AVP-923, has been accepted by the U.S. Food and Drug Administration (FDA). Upcoming Phase II/III studies will assess the drug's efficacy in reducing the loss of emotional control, clinically known as emotional lability, in patients with neurodegenerative diseases such as Multiple Sclerosis (MS), Lou Gehrig's disease (ALS), Alzheimer's Disease (AD) and stroke.
Assuming successful initiation of Phase II/III clinical trials for emotional lability, the company plans to initiate product development for the additional indications, neuropathic pain and chronic cough. If all three indications are successfully developed and marketed by the company, the addressable market would be in excess of 1.5 billion. |