Avanir Pharmaceuticals has completed targeted enrolment of patients into the STAR trial, a confirmatory phase-III trial of Zenvia (dextromethorphan/quinidine [DM/Q]) in patients exhibiting signs and symptoms of pseudobulbar affect (PBA). The randomized, multi-centre, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on involuntary crying/laughing episodes rates.
"The completion of patient enrolment into the STAR trial is an important clinical milestone for Avanir," said Dr Randall Kaye, Avanir's chief medical officer. "We look forward to unblinding the data in the third calendar quarter of this year and plan to submit our complete response to the approvable letter in the first half of 2010."
The STAR trial had a targeted enrolment of 120 patients with multiple sclerosis (MS) and 180 patients with amyotrophic lateral sclerosis (ALS) who exhibit signs and symptoms of PBA at approximately 50 sites in the US and Latin America. The primary efficacy analysis is based on the changes in crying/laughing episode rates recorded in patient diaries.
Secondary endpoints for this clinical trial include centre for Neurologic Study-Lability Scale (CNS-LS) score; Neuropsychiatric Inventory Questionnaire (NPI-Q); SF-36 Health Survey; Beck Depression Inventory (BDI-II); and Pain Rating Scale score (MS patients only). Safety and tolerability of Zenvia are determined by reporting adverse events, physical exam, vital signs, electrocardiogram, respiratory function tests and clinical assessment of clinical laboratory variables.
Zenvia is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan.
Avanir Pharmaceuticals is focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of chronic diseases.