AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR), 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.
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."
About PBA
Pseudobulbar affect (PBA) is a neurologic condition characterized by involuntary, sudden, and frequent episodes of laughing and/or crying in patients with underlying neurologic disease or injury. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. In addition to the burden of the underlying neurologic disorder, PBA can have a number of problematic individual and socially disabling consequences, which may depend upon the frequency and severity of the laughing and crying episodes. The etiology of PBA is not completely understood but the symptoms of PBA are similar across patient populations. The pathophysiology of PBA is widely believed to involve injury to the neurologic pathways that regulate affect. PBA is estimated to occur in 49% of patients with ALS, in 10% of patients with MS, in 11% of patients 1 year after suffering a stroke, and in 11% of patients after a traumatic brain injury. PBA has also been reported secondary to a number of other neurologic conditions. There are currently no FDA-approved treatments for PBA.
Source
ZENVIA