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PHARMACEUTICALS
Untitled Page Published: August 11, 2009 02:45 AM



AVANIR, continued ...

"Frequent, unpredictable and often intense emotional outbursts may take a devastating toll on patients with PBA and their loved ones,” says Jeffrey Cummings, M.D., Augustus Rose professor of Neurology at the David Geffen School of Medicine at UCLA and steering committee chairman for the STAR trial. “The results of the STAR trial indicate that the new low dose formulation of Zenvia can substantially reduce the number of PBA episodes that these patients experience."

Currently there are no FDA-approved treatments available for PBA, which constitutes a desperate medical need for the estimated 2 million patients in the U.S. living with the condition.

“We are very encouraged by the top-line results and we believe that the STAR data should be sufficient to address the issues outlined in the FDA approvable letter,” Keith Katkin, president and CEO of AVANIR. “We hope to have a full presentation of the STAR trial results at a scientific meeting later this year and plan to submit our complete response to the FDA in the first half of 2010."

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