AVANIR Pharmaceuticals Announces Zenvia Review Timeline Established by FDA with PDUFA Date of October 30, 2010
ALISO VIEJO, Calif., May 17, 2010 - AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Company's Complete Response to the October 2006 Approvable Letter for Zenvia™ (dextromethorphan/quinidine) in the treatment of pseudobulbar affect (PBA). The FDA considers this a Class 2 response and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2010.
'If approved, Zenvia will be the first FDA approved treatment available for patients suffering from PBA,' said Randall Kaye, AVANIR's Chief Medical Officer. 'We look forward to working closely with the agency during the upcoming months through the remaining stages of the review process.'
Pseudobulbar affect (PBA) is a neurologic condition characterized by involuntary, sudden, and frequent episodes of laughing and/or crying in patients with certain underlying neurologic diseases or injuries. 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 be disabling, 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. There are currently no FDA approved treatments for PBA. Further information about pseudobulbar affect can be found at www.PBAinfo.org.
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 pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity.
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). AVANIR has filed an application for regulatory approval in the PBA indication and expects an FDA approval decision in the fourth calendar quarter of 2010. 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. AVANIR has also completed a Phase III trial of Zenvia in patients with diabetic peripheral neuropathic (DPN) pain. Further information about AVANIR can be found at www.avanir.com and further information about pseudobulbar affect can be found at www.PBAinfo.org.
FORWARD LOOKING STATEMENTS
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 meet expected review timelines or approve Zenvia for any indication. 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.
AVANIR Pharmaceuticals, Inc.
Eric Benevich or Brenna Mullen, 949-389-6700
May 17, 2010