Efficacy and safety data should be sufficient to meet FDA’s requirements as per a 2006 approvable letter.

Avanir Pharmaceuticals reports that Zenvia™ met its primary efficacy endpoint in the treatment of pseudobulbar affect (PBA) in a Phase III trial. PBA refers to the pathological expression of laughter, crying, or smiling in inappropriate situations.

Both doses studied provided a statistically significant reduction in episode rates during the study when compared to placebo. Additionally, adverse events were mild to moderate.

“Frequent, unpredictable, and often intense emotional outbursts may take a devastating toll on patients with PBA and their loved ones,” says Jeffrey Cummings, M.D., Augustus Rose professor of neurology at the David Geffen School of Medicine at UCLA and steering committee chairman for this study. It is most commonly observed after brain injury, in people with dementia expressing a psychosis of some sort, or with degeneration in amyotrophic lateral sclerosis.

The Phase III data should be sufficient to address the issues outlined in FDA’s approvable letter, which was received in October 2006, states Keith Katkin, president and CEO. At the time the agency asked for additional safety and efficacy data.

The primary efficacy analysis in the late-stage study was based on the changes from baseline in crying/laughing episode rates recorded by patients. Zenvia 30/10 mg provided a 47.2% incremental reduction in episode rates compared to placebo over the course of the study. In a secondary analysis, Zenvia 20/10 mg also provided a statistically significant incremental reduction of episode rates compared to placebo.

An important secondary endpoint analysis was based on the change from baseline to end of study using the Center for Neurologic Studies Lability Scale (CNS-LS). In this secondary endpoint analysis, patients receiving Zenvia 30/10 mg reported a significantly greater reduction in mean CNS-LS score compared to patients who received placebo.

Overall, Zenvia was generally safe and well tolerated in this study. Reported adverse events were generally mild to moderate in nature. The most commonly reported adverse events that appeared to be more frequent than placebo were dizziness, nausea, and diarrhea.

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