ALAMEDA, Calif., March 14, 2007 (PRIME NEWSWIRE) (PRIMEZONE) -- Avigen, Inc. (Nasdaq:AVGN) a biopharmaceutical company developing innovative therapies for the treatment of neurological conditions, today announced it was given approval from the U.S. Food and Drug Administration to commence Phase II clinical development of AV650 (tolperisone). AV650 is a New Chemical Entity (NCE) in the United States. Tolperisone is approved in several EU member countries for the treatment of spasticity and muscle spasms. Avigen's initial Phase II trial will assess the safety, tolerability, and initial efficacy, as well as AV650's lack of sedation, in spinal cord injury patients suffering from spasticity. This study will be a multi-center, double-blind, placebo-controlled trial and will explore doses up to the EU approved dose of 450 mg per day.
