"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."
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."