Tuesday, Avanir Pharmaceuticals, Inc. (AVNR) said a low dose formulation of its investigational drug Zenvia was found to provide statistically significant sustained efficacy in pseudobulbar affect patients in a 12-week open-label extension to the Phase III study. The company said it plans to submit a complete response to FDA's approvable letter in the second quarter of 2010 and expects a decision after six months.
Randall Kaye, MD, chief medical officer of Avanir, said, "These long term STAR data suggest that the new low dose formulation of Zenvia provides sustained efficacy by reducing the frequency and severity of pseudobulbar affect episodes over a 6 month treatment period."
Keith Katkin, chief executive officer of Avanir, said, "These open-label data from the extension phase of the STAR trial are the final data elements necessary to submit a complete response to the FDA approvable letter. Our team is working to file a complete response early in the second calendar quarter of 2010, with an FDA approval decision expected approximately six months later. If approved by the FDA, we hope to make Zenvia available as quickly as possible to the significant number of patients in the U.S. currently suffering from the debilitating episodes of PBA."
The 12-week open-label extension phase of the confirmatory Phase III STAR trial was conducted to evaluate Zenvia, a combination of dextromethorphan and quinidine, for the treatment of patients with pseudobulbar affect, or PBA.
In the open-label study, the efficacy endpoint analysis was based on the change from baseline to end of study using the Center for Neurologic Studies Lability Scale, or CNS-LS, which is used to measure the severity and intensity of PBA.
Patients originally receiving Zenvia 30/10 mg in the double-blind phase reported a statistically significant treatment response over the course of their second 12 weeks of treatment compared to open-label baseline.
In addition, patients that switched to Zenvia 30/10 mg from either Zenvia 20/10 mg or placebo achieved a statistically significant incremental improvement in their CNS-LS scores compared to baseline over the 12-week treatment period, the company said.
During the study, early withdrawal due to adverse events occurred in 4% of patients and the reported events were generally mild to moderate in nature. The percentage of patients reporting at least one serious adverse event, or SAE, was 5.5%. A total of 14 patients experienced SAEs over the course of the study. No cardiovascular SAEs were reported, the company noted.
Pseudobulbar affect, also known as emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays. There are no FDA-approved treatments for PBA at present.
Moderate to severe PBA is estimated to impact two million people in the United States with underlying neurologic conditions such as multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, dementias including Alzheimer's disease, stroke, and traumatic brain injury.
AVNR is gaining $0.17 or 9.14%, and is trading at $2.03 on a volume of 62 thousand shares on the Nasdaq.
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