AVANIR stock rockets on positive Ph III Zenvia data

US firm AVANIR Pharmaceuticals' share price rose 76% to $3.85 in premarket trading on August 11 after closing at $2.19 during regular trading the previous day, when it. announced that Zenvia (dextromethorphan/quinidine) met its primary efficacy endpoint in the treatment of pseudobulbar affect (PBA) in the confirmatory Phase III STAR trial. The news successfully addressed safety concerns from the US Food and Drug Administration, which, in 2006, suggested that one of Zenvia's ingredients, quinidine, might pose cardiovascular risks in some patients if the firm doubled the recommended dosage to compensate for a missed regimen.

Both Zenvia 30/10mg and 20/10mg provided a statistically-significant reduction in episode rates over the course of the study when compared to placebo (p<0.0001). in an additional analysis of the primary endpoint, at week 12 (end of study), patients in the zenvia 30/10mg group reported a statistically-significant mean reduction of 88% from baseline in pba episode rates (p="0.01)." also in this study, zenvia was generally safe and well tolerated. >

"Frequent, unpredictable and often intense emotional outbursts may take a devastating toll on patients with PBA and their loved ones. The results of the STAR trial indicate that the new low dose formulation of Zenvia can substantially reduce the number of PBA episodes that these patients experience," said Jeffrey Cummings, Augustus Rose Professor of Neurology at the David Geffen School of Medicine at UCLA, USA and Steering Committee Chairman for the STAR trial. "With no FDA approved treatments currently available, there is a real unmet medical need for the estimated 2 million patients in the U.S. living with the burden of PBA," he added.