AVANIR's STAR trial Phase III data to be presented at the World Congress on Controversies in Neurology

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AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced it will present detailed data from the Phase III confirmatory STAR trial in the treatment of pseudobulbar affect (PBA) at the 3rd World Congress on Controversies in Neurology (CONy) in Prague, Czech Republic on October 8 - 11, 2009 and the American Neurological Association (ANA) 134th Annual Meeting in Baltimore, MD on October 11 - 14, 2009.

At the CONy meeting, the poster session will take place on Friday, October 9, between 7:30 a.m. and 8:30 a.m. Central Europe Time (CET). This late-breaker poster will feature data from the cohort of multiple sclerosis (MS) patients with PBA in the STAR trial, including the previously unreleased secondary efficacy endpoint of CNS-LS and MS-related pain.

The accepted poster is:

  • Poster number 11: DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL STUDY OF AVP-923 FOR PSEUDOBULBAR AFFECT IN MS

At the ANA meeting, the poster session will take place on Tuesday, October 13, between 1:00 p.m. and 2:00 p.m. Eastern Time (ET). This late-breaker poster will feature the full double-blind data set from the STAR trial, including previously unreleased additional analyses of the primary endpoint and all of the secondary efficacy endpoints.

The accepted poster is:

  • Poster number WIP-24: DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF AVP-923 FOR PSEUDOBULBAR AFFECT

“We are very pleased that these exciting new data have been accepted for late-breaker presentations,” said Randall Kaye, MD, AVANIR’s Chief Medical Officer. “We look forward to sharing the full STAR trial double-blind data set as well as data from the MS cohort. These data provide additional insight into the utility of Zenvia in PBA as well as other areas of potential clinical development. We believe the full data set further demonstrates that the new lower dose formulations of Zenvia offer an improved product profile and we remain on track to submit a full response to the FDA in the first half of 2010 with an approval decision anticipated in the second half of next year.”

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