AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) today announced the electronic publication of the results of the pivotal Phase III STAR trial of its investigational drug AVP-923 (dextromethorphan/quinidine) in the Annals of Neurology. The publication entitled "Dextromethorphan Plus Ultra-Low-Dose Quinidine Reduces Pseudobulbar Affect" evaluated two low dose formulations compared to placebo in the treatment of pseudobulbar affect (PBA) in patients with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). PBA is a neurologic condition characterized by involuntary, unpredictable and disruptive outbursts of laughing or crying in patients with certain underlying neurologic diseases or injuries.
"Outbursts of crying or laughter at inappropriate times can have a severe impact on patients," said study author Erik P. Pioro, MD, PhD, FRCPC, Director of the Section for ALS and Related Disorders at the Cleveland Clinic in Cleveland, Ohio. "In the STAR trial, both doses of AVP-923 markedly reduced the frequency and severity of PBA episodes with satisfactory safety and tolerability. The findings expand the clinical evidence that AVP-923 may someday be an important treatment option for neurologic patients suffering from PBA."
"There are a significant number of patients in the U.S. currently untreated and suffering from sudden and disruptive episodes of PBA. We are honored that the STAR trial results have been published in such a prominent journal. It is indicative of the importance of the data and degree of unmet medical need among patients with PBA," stated Randall Kaye, MD, Chief Medical Officer, AVANIR Pharmaceuticals.
STAR (Safety, Tolerability and Efficacy Results of AVP-923 in PBA), a randomized, blinded, controlled, multicenter Phase III trial in patients with PBA, compared active treatment with AVP-923 30/10 mg BID or 20/10 mg BID to placebo over 12 weeks, followed by a 12-week, open-label safety extension study. At the conclusion of enrollment, 326 patients were enrolled (197 with underlying ALS and 129 with underlying MS) who exhibited signs and symptoms of PBA.
Please visit the Annals of Neurology website at http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1531-8249/earlyview to read the authors' interpretation and conclusions of the Phase III STAR trial clinical data.
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