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ALISO VIEJO, Calif.,
Oct. 23, 2012 /PRNewswire/ --
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that The Michael J. Fox Foundation has awarded the company a grant to evaluate the safety and efficacy of AVP-923 (dextromethorphan hydrobromide and quinidine sulfate) for the treatment of levodopa-induced-dyskinesia (LID) in Parkinson's disease (PD).
"The development of effective drugs that can reliably suppress L-dopa-induced dyskinesia is a very high priority in Parkinson's research," said
Anthony E. Lang, MD, Professor and Director of the Division of Neurology and Chair for Parkinson's Disease Research at the
University of Toronto. "I am excited at the prospects of the work being done by The Michael J. Fox Foundation and Avanir directed at this important unmet need in the Parkinson's community."
"We are proud to be recognized by The Michael J. Fox Foundation with this award," said
Joao Siffert MD, senior vice president of research and development at Avanir and principal investigator of the study. "Their support will enable this important study in LID and further validates the rationale for testing AVP-923 for diverse central nervous system disorders of high unmet medical need."
About the StudyThis proof-of-concept, double blind, randomized, crossover study will compare AVP-923 (45 mg of dextromethorphan / 10 mg of quinidine) with placebo for treatment of LID. The study will enroll PD patients across three study centers in the US and
Canada. Study participants will receive, in a random order, a 2-week treatment with AVP-923 and a 2-week placebo treatment, separated by a 2-week break. At the end of each 2-week treatment period, patients will receive a 2-hour levodopa infusion to test the drug effect on dyskinesia. Patients will be carefully monitored throughout the 6-week study for side effects, Parkinson's symptoms and general health status. The results of this study will help inform future development of AVP-923 for LID.
AVP-923 is not approved for the treatment of levodopa-induced-dyskinesia in patients with Parkinson's disease.