Avanir Announces Progress on Zenvia Development

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Feb 5, 2008 - AVANIR Pharmaceuticals (NASDAQ:AVNR) today provided a progress update on its large, formal pharmacokinetic (PK) study of its investigational drug Zenvia (dextromethorphan/quinidine (DM/Q)). Findings from the formal PK study will be used to support identification of an alternative formulation of Zenvia for diabetic peripheral neuropathic (DPN) pain. The alternative dose formulation is intended to deliver similar efficacy as observed in the first Phase III clinical study in DPN pain but with an improved safety and tolerability profile. The Company has completed the first three dosage cohorts in the formal PK study and has initiated the last two dosage cohorts. Data from the first three dosage cohorts indicate that there were no serious adverse events (SAEs) reported and only 1 of 48 subjects discontinued the study.

"Completing the formal PK study will allow us to engage in a meaningful dialogue with the U.S. Food and Drug Administration (FDA) regarding the next steps in the development of Zenvia for the treatment of DPN pain," said Dr. Randall Kaye, Chief Medical Officer for AVANIR Pharmaceuticals. "Upon completion of this study we hope to identify an alternative Zenvia formulation that will yield dextromethorphan plasma concentrations sufficient to confer an efficacy benefit similar to that previously observed in our successful Phase III DPN pain trial while simultaneously offering an improved safety and tolerability profile."

"Findings from this PK study will help us select a dose that will optimize safety and efficacy for our next Phase III trial of Zenvia in patients with DPN pain," said Keith Katkin, AVANIR's President and CEO. "I am pleased that our clinical development team has executed this study on an accelerated timeline. In view of the progress to date, we now expect to release top-line data during the second calendar quarter of 2008."

Formal PK Study Design

The formal PK study is a single center, randomized, double-blind, placebo-controlled, parallel-group, multiple dose pharmacokinetic evaluation of various dose combinations and regimens of DM and Q. Safety will be determined by evaluating vital signs, laboratory parameters, ECGs, physical examination, and by recording adverse events during the treatment period. The Company plans to enroll a total of 80 subjects in the study. The subjects will be randomized to receive one of the following oral dose combinations for 8 days (10 of the 80 subjects will receive placebo): -0-


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                           Zenvia Dose (DM/Q)     Dosing Frequency

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     Dosage Cohort 1             30/10         TID (three times daily)

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                                 30/10         BID (two times daily)

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                                 45/30         BID (two times daily)

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-0-

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                             Zenvia Dose (DM/Q)    Dosing Frequency

                            ------------------------------------------

      Dosage Cohort 2              60/15         BID (two times daily)

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                                   60/15            QD (once daily)

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About Zenvia

Zenvia 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. Zenvia is currently in development for the treatment of pseudobulbar affect (PBA) and diabetic peripheral neuropathic (DPN) pain. In October 2006, the Company received an approvable letter for the treatment of Zenvia in PBA. The Company has initiated a confirmatory Phase III study under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) utilizing a new lower quinidine dose formulation of Zenvia intended to address safety concerns raised in the Agency's approvable letter for Zenvia in the treatment of PBA. For more information about the Agency's SPA process see http://www.fda.gov/cder/guidance/3764fnl.htm. In April 2007, AVANIR announced successfully meeting all primary endpoints in a Phase III study of Zenvia in DPN pain. The Company is conducting the aforementioned formal pharmacokinetic (PK) study to assess alternative lower-dose quinidine formulations of Zenvia for DPN pain that are intended to deliver similar efficacy and improved safety/tolerability versus the formulations previously tested for this indication.

About AVANIR

AVANIR Pharmaceuticals is focused on developing, acquiring and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's products and product candidates address therapeutic markets that include the central nervous system (CNS), inflammation and infectious diseases. AVANIR's lead product candidate, Zenvia, is being developed for the treatment of pseudobulbar affect (PBA) and is the subject of an approvable letter from the U.S. Food and Drug Administration (FDA) for that indication. The Company has initiated a confirmatory Phase III study under a Special Protocol Assessment (SPA) agreement with the FDA utilizing a new lower quinidine dose formulation of Zenvia intended to address safety concerns raised in the Agency's approvable letter for Zenvia in the treatment of PBA. Additionally, in April 2007 AVANIR announced meeting all primary endpoints in a Phase III clinical trial with Zenvia in patients with diabetic peripheral neuropathic (DPN) pain. The Company is conducting the aforementioned formal pharmacokinetic (PK) study to assess alternative lower-dose quinidine formulations of Zenvia for DPN pain that are intended to deliver similar efficacy and improved safety/tolerability versus the formulations previously tested for this indication. AVANIR has also licensed a compound to Novartis International Pharmaceuticals Ltd. for the treatment of inflammatory disease. AVANIR's infectious disease drug candidate, AVP-21D9, is a human monoclonal antibody in pre-clinical development for the treatment of anthrax with funding provided to date from NIH/NIAID grants. The Company's first commercialized product, Abreva(R), 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.

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," 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. There can be no assurance that the Company will be able to complete clinical trials and the pharmacokinetic (PK) study within the projected time periods. There can also be no assurance that the PK study will identify one or more new doses of Zenvia that have the desired efficacy and an acceptable safety/tolerability profile, or that the U.S. Food and Drug Administration (FDA) will 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.

To be included on AVANIR's e-mail alert list, click on the link below or visit AVANIR's website: http://www.b2i.us/irpass.asp?BzID=958&to=ea&s=0.

Contact

Lippert/Heilshorn & Associates, Inc.
Jody Cain (jcain@lhai.com)
Bruce Voss (bvoss@lhai.com)
310-691-7100

Posted: February 2008

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