Avanir Pharmaceuticals, Inc., a biopharmaceutical company focused on bringing innovative medicines to patients with CNS disorders of high unmet medical need, announced that the US Food and Drug Administration (FDA) has agreed to an expedited development pathway for its  next-generation compound, AVP-786, requiring only a limited pre-clinical package as part of the Investigational New Drug (IND) application. Upon completion of these preclinical studies the company intends to proceed directly into human clinical trials.

"We are very pleased with the outcome of our recent meeting with the Division of Neurology of the FDA," said Joao Siffert, MD, Avanir's chief scientific officer. "Avanir will be allowed to reference the extensive data generated during AVP-923 development programmes in support of the AVP-786 IND and subsequent new drug application. This has the potential to substantially reduce the cost and time to market. We anticipate that we will be able to seamlessly integrate AVP-786 into our ongoing development programmes in neuropathic pain, agitation in Alzheimer's disease and levodopa induced dyskinesia in Parkinson's disease."

AVP-786 is a novel investigational drug product consisting of a combination of deuterium modified dextromethorphan (a new chemical entity or NCE) and ultra-low dose quinidine, used as a metabolic inhibitor. Incorporation of deuterium into specific positions of the dextromethorphan molecule strengthens the chemical bonds and reduces susceptibility to enzyme cleavage and first pass metabolism, but without altering its pharmacology. AVP-786 is an investigational drug not approved by the FDA.

AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is being studied in several ongoing clinical trials including agitation in Alzheimer's disease, neuropathic pain in multiple sclerosis, levodopa-induced dyskinesia in Parkinson's disease, and behavioral symptoms of autism. AVP-923 for the above investigational uses has not been approved by the FDA.

Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need.