AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR), today announced it will present three scientific posters featuring detailed Zenvia™ (dextromethorphan/quinidine) safety and efficacy data from the double-blind phase and the open label extension of the Phase III confirmatory STAR trial at the American Academy of Neurology (AAN) Annual Meeting in Toronto, Canada, taking place April 10 - 17, 2010.
“We look forward to sharing the detailed Zenvia data in Toronto which demonstrate a durable treatment response over 6 months as well as a favorable safety and tolerability profile.”
The first Zenvia data poster will be presented on Tuesday, April 13, between 3:00 p.m. and 7:30 p.m. Eastern Daylight Time (EDT). The poster will feature efficacy data from the 12-week, open label extension study of Zenvia in the treatment of patients with pseudobulbar affect (PBA) and was selected by the American Academy of Neurology as part of the Late-Breaking Science program. Abstracts that qualify for Late-Breaking Science presentations must be of sufficient scientific importance or interest to warrant expedited presentation and publication.
The accepted late-breaker poster is:
- Poster number P02.295: PERSISTENT EFFICACY OF DEXTROMETHORPHAN (DM)/QUINIDINE (Q) FOR PSEUDOBULBAR AFFECT (PBA): RESULTS FROM A 12-WEEK, OPEN-LABEL EXTENSION (OLE) STUDY
The second presentation includes two Zenvia data posters and will take place on Thursday, April 15, between 3:00 p.m. and 7:30 p.m. EDT. The posters will feature cardiac safety data from the double-blind phase of the STAR trial and safety and tolerability data from the open label extension study of Zenvia in the treatment of patients with PBA.
The accepted posters are:
- Poster number P06.119: SUMMARY OF CARDIAC SAFETY FROM A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF DEXTROMETHORPHAN/QUINIDINE (STAR) FOR TREATMENT OF PSEUDOBULBAR AFFECT
- Poster number P06.128: SAFETY AND TOLERABILITY OF DEXTROMETHORPHAN/QUINIDINE FOR PSEUDOBULBAR AFFECT IN A 12-WEEK OPEN-LABEL EXTENSION STUDY
"We are very pleased that these important data have been accepted for presentation at the AAN Annual Meeting and that the long-term efficacy data were selected for inclusion in the Late-Breaking Science program," said Randall Kaye, MD, AVANIR's Chief Medical Officer. "We look forward to sharing the detailed Zenvia data in Toronto which demonstrate a durable treatment response over 6 months as well as a favorable safety and tolerability profile."