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Avanir drug shows promise for MS-related pain

Fri Oct 9, 2009 10:43am EDT

(Reuters) - Avanir Pharmaceuticals Inc (AVNR.O) said a late-stage trial of its neurological drug Zenvia showed encouraging proof of concept data in relieving pain associated with multiple sclerosis (MS), sending its shares up more than 16 percent.

Additional data from its STAR trial, which tested Zenvia as a treatment for pseudobulbar affect (PBA), showed that the 30/10 mg dose of the drug reduced MS-related pain in a small subset of patients with moderate-to-severe pain, Avanir said.

PBA is a condition in which patients cannot control outbursts of crying or laughing. It affects an estimated 2 million Americans with multiple sclerosis, Lou Gehrig's disease (ALS), stroke and other neurological diseases or trauma that can cause brain lesions.

In August, the company said Zenvia met the main goal of the STAR trial by cutting emotional outbursts by 47.2 percent compared to placebo and both doses of the drug, 30/10 mg and 20/10 mg provided a statistically significant reduction in episode rates compared to placebo.

The STAR trial enrolled a total of 326 patients, 197 with ALS and 129 with MS, who exhibited signs and symptoms of PBA across 52 sites in the United States and Latin America.

On Friday, the company said while the 30/10 mg dose significantly reduced PBA episode rates by 11.9 percent beyond placebo in patients with MS, the 20/10 mg dose did not achieve a statistically significant reduction.

The company also said that both Zenvia groups demonstrated a numerical reduction in mean CNS-LS scores but did not achieve statistical significance versus placebo in the subset of MS patients.

The CNS-LS scores, which measures the frequency and severity of PBA, was a secondary goal in the trial. Overall, Zenvia was generally safe and well tolerated in the MS population, the company said.

Shares of Avanir were up 16 cents at $2.46 in morning trade on Nasdaq. They touched a high of $2.68 in early trade.

(Reporting by Jennifer Robin Raj in Bangalore; Editing by Gopakumar Warrier)

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