UPDATE 1-Avanir posts positive Zenvia data, shares rise

Tue Nov 10, 2009 2:44pm GMT
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* Final data shows drug safe, effective and well tolerated

* Shares rise 11 pct

Nov 10 (Reuters) - Avanir Pharmaceuticals Inc (AVNR.O: Quote, Profile, Research) said final data from a late-stage trial of its experimental neurological disorder drug showed that it was safe, effective and well tolerated, sending the company's shares up 11 percent.

The drug, Zenvia, treats pseudobulbar affect (PBA), a condition in which patients cannot control outbursts of crying or laughing.

In the late-stage trial, named STAR, patients on 30/10 mg dose of the drug showed statistically significant incremental improvement according to a standard measure of the severity and intensity of the disorder over an additional 12-week treatment period.

In addition, patients who switched to Zenvia 30/10 mg dose from either Zenvia 20/10 mg dose or a dummy drug achieved a statistically significant incremental improvement which was maintained over the 12-week treatment period.

The drug was also safe and well tolerated, with low rates of adverse events.

Avanir had received an approvable letter from the U.S. health regulators about three years ago, asking it to perform new trials with a reformulated version of Zenvia on safety concerns.

"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," Chief Executive Keith Katkin said in a statement.  Continued...

 
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