AVANIR Pharmaceuticals to Present Zenvia Phase III Data at American Academy of Neurology Annual Meeting
ALISO VIEJO, Calif., April 6, 2010 - 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.
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:
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:
"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."
Copies of the posters will be available on the Company's website at www.avanir.com after being presented. Copies can also be obtained from the Company by request at 101 Enterprise, Suite 300, Aliso Viejo, CA 92656.
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.
Zenvia™ (dextromethorphan/quinidine) is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways: through presynaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia has completed a confirmatory Phase III trial in the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. In October 2006, the Company received an FDA approvable letter for Zenvia in the treatment of PBA. The Company conducted the confirmatory Phase III STAR trial under a Special Protocol Assessment (SPA) agreement with the FDA with the goal of addressing safety concerns raised in the Agency's approvable letter for Zenvia in the treatment of PBA. AVANIR plans to file a full response to the approvable letter in the second calendar quarter of 2010, with an FDA approval decision expected in the fourth calendar quarter.
AVANIR Pharmaceuticals, Inc., is a biopharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders. AVANIR's lead product candidate, Zenvia, has completed a confirmatory Phase III trial in the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. AVANIR plans to file an application for regulatory approval in the PBA indication in the second calendar quarter of 2010, with an FDA approval decision expected in the fourth calendar quarter. AVANIR sold its anthrax monoclonal antibody program to Emergent BioSolutions. The Company's first commercialized product, Abreva® (docosanol), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com and further information about pseudobulbar affect can be found at www.PBAinfo.org.
Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. For example, there can be no assurance that the U.S. Food and Drug Administration (FDA) will approve Zenvia for any indication, or that the Company will meet projected timelines. Risks and uncertainties affecting the Company's financial condition and operations also include the risks set forth in AVANIR's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time to time in other publicly available information regarding the Company. Copies of this information are available from AVANIR upon request. AVANIR disclaims any intent to update these forward-looking statements.
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Eric Benevich or Brenna Mullen, 949-389-6700
Posted: April 2010