10-09-09
Avanir posts mixed late stage Zenvia study results
ALISO VIEJO, Calif. — Avanir Pharmaceuticals Inc. on Friday reported mixed results for its drug candidate Zenvia, which is intended to reduce involuntary emotional outbursts in patients with neurological disorders.
In a late stage trial, Avanir was testing two doses of Zenvia against emotional outbursts in patients with multiple sclerosis and amyotrophic lateral sclerosis. The lower dose did not significantly reduce the number of those events compared to placebo, but the higher dose did, the company said.
In morning trading, Avanir shares rose 18 cents, or 7.8 percent, to $2.48.
The study tested Zenvia as a treatment for pseudobulbar effect, or emotional reactions such as uncontrollable laughing or crying. The condition is associated with some neurological disorders, including multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's disease, Parkinson's disease, and damage caused by stroke or brain injury, Avanir said. The company said there are no approved treatments for the condition.
Avanir's trial included 197 patients with ALS, or Lou Gehrig's disease, and 129 with MS. Avanir said Zenvia did not lead to a statistically significant reduction in the severity of the outbursts. The higher dose of the drug also relieved multiple sclerosis related pain, Avanir said.
Zenvia is a combination of two drugs, dextromethorphan and quinidine. Dextromethorphan is also a common ingredient in cough and cold medicines because it can suppress coughing. Avanir is also testing Zenvia as a treatment for peripheral diabetic nerve pain.
The company said the drug was safe, and three patients left the 12-week study because of side effects. All of those patients were in the lower dose group. The most common side effects were dizziness, nausea, diarrhea, tiredness and colds.
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