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Avanir Pharma: Neurological Drug Meets Goal In Extended Trial

DOW JONES NEWSWIRES

Avanir Pharmaceuticals Inc. (AVNR) said the new low-dose version of neurological disorder pill Zenvia reduced the frequency and severity of uncontrollable emotional outbursts in patients with multiple sclerosis over a six-month treatment period.

Shares rose 9.7% to $2.04 premarket. The stock has more than quadrupled this year.

Avanir on Monday said that patients maintained on a 30/10 milligram dose of Zenvia continued to show significant incremental improvement in reducing episodes of the pseudobulbar affect during an additional 12 weeks of its late- stage study.

Chief Medical Officer Randall Kaye said it was the first time the treatment's efficacy has been studied beyond 12 weeks, and that it demonstrated favorable long-term safety and tolerability.

President and Chief Executive Keith Katkin said the company expects to file a complete response to the FDA early in the second quarter of next year, with any FDA approval expected about six months later.

The company last month said that in its initial phase III trial, a 30/10 milligram dose of Zenvia met a primary endpoint by reducing pseudobulbar affect- -a condition that manifests in outbursts like uncontrollable laughing or crying- -among MS patients. At the time, Avanir said it also reduced pain in MS patients.

About three years ago, the Food and Drug Administration told Avanir to reformulate and retest Zenvia because of safety worries. Data released in August showed it proved effective in treating the pseudobulbar effect. In the U.S., it appears in an estimated two million patients with multiple sclerosis, Lou Gehrig's disease, stroke and other neurological diseases or trauma resulting with brain lesions.

-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com;

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