Avanir Reveals Results Of Phase III Star Trial

Avanir Pharmaceuticals has released the results from the confirmatory double-blind phase III star trial evaluating two doses of the investigational drug Zenvia compared to placebo in the treatment of pseudobulbar affect (PBA) among patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS).

The study revealed that Zenvia 30/10mg met the primary efficacy endpoint by reducing PBA episode rates by an incremental 11.9% beyond placebo (p=0.0280). The lower dose Zenvia 20/10mg group did not achieve a statistically significant reduction in PBA episode rates compared to placebo.

Daniel Wynn, MD, director, clinical research, co-director, consultants in Neurology Multiple Sclerosis Center and STAR Trial steering committee member, said: “PBA represents an area of high unmet medical need with no FDA-approved treatments currently available. Although the involuntary emotional outbursts of PBA cause considerable impairment for millions of individuals in the United States, it is under recognized and commonly misdiagnosed. If approved, Zenvia will be an important treatment option to ameliorate the profound distress caused by PBA among individuals afflicted with neurologic disease or injury and their caregivers.”

Randall Kaye, chief medical officer at Avanir, said: “We were very pleased that Zenvia demonstrated significant improvement in PBA episodes in the MS sub-population as well as encouraging proof of concept data in MS-related pain. This is especially exciting given that the Star trial was not powered to detect an efficacy signal in such a small number of patients. These data provide additional insight into the clinical utility of Zenvia and help shape our plans for future drug development.”