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AVANIR Announces 120 Day Safety Update From Ongoing Open Label Study and Topline Results From QT Study

Posted on: Monday, 5 June 2006, 09:00 CDT

AVANIR Pharmaceuticals (Nasdaq:AVNR) today announced the submission of additional data from its ongoing open label study assessing safety in chronic exposure to Neurodex(TM), an investigational new drug that is the subject of a new drug application (NDA). Neurodex is currently in priority review at the U.S. Food and Drug Administration (FDA) for the treatment of involuntary emotional expression disorder (IEED), and in Phase III clinical development as a potential treatment for painful diabetic neuropathy.

The results of the 120 day safety update were consistent with prior data from the Neurodex IEED trials and were submitted to the FDA. Additional results from this study will continue to be reported to the FDA during the NDA review period every 120 days, until the Company ends the study. Top-line results are provided in the table below: Treatment Phase(a) Extension Phase(b) (n=506) (n=201) ---------------------------------------------------------------------- Total adverse events 446 (88.1%) 165 (82.1%) Nausea 121 (23.9%) 15 (7.5%) Headache 113 (22.3%) 20 (10.0%) Dizziness 95 (18.8%) 14 (7.0%) Diarrhea 82 (16.2%) 10 (5.0%) Mean QTcF (min/max) 405.7 msec 405.1 msec (283/480 msec) (344/505 msec) Mean change QTcF 3.9 msec (-125/66 msec) 3.7 msec (-68/50 msec) (min/max) ---------------------------------------------------------------------- (a) 1 to 12 months in study (b) Over 1 year in study

Interim data from the ongoing open label safety trial were presented at a podium presentation on Friday, June 2, 2006 at the 2006 Annual Conference of the Consortium of Multiple Sclerosis Centers in Phoenix, Ariz. James P. Wymer, M.D., Ph.D., presented safety data from AVANIR's Phase III trial with multiple sclerosis (MS) patients with IEED and interim data from the open label safety study. Additionally, a poster, Reduction in Pain Intensity in Multiple Sclerosis Patients With Involuntary Emotional Expression Disorder Treated With AVP-923, was presented at the meeting of healthcare professionals.

A thorough QT study to determine the electrocardiogram changes associated with Neurodex was also recently completed and will be submitted to the FDA. "While a thorough QT study was not requested as part of our IEED NDA, we chose to conduct one now as part of our clinical development program exploring the drug's potential use in the treatment of painful diabetic neuropathy," said Randall Kaye, M.D., Vice President of Medical Affairs of AVANIR. "We are satisfied that the results of this study characterized the QT effects of Neurodex and believe that the addition of the study rounds out our investigational new drug's safety profile."

The protocol for the QT study was submitted to the FDA for review and comment and was performed consistent and in compliance with the principles of the International Conference on Harmonization (ICH) guidance on "The Clinical Evaluation of QT/QTC Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs." Top-line results are provided in the table below: Neurodex Supratherapeutic Moxifloxacin (standard NDX (2x Positive dose) standard dose) Control (400 mg) ---------------------------------------------------------------------- Outlier absolute values (greater than 480 msec) 0 (0%) 0 (0%) 0 (0%) Outlier absolute values (450-480 msec) 0 (0%) 2 (0.57%) 0 (0%) Outlier delta change (greater than 60) 0 (0%) 0 (0%) 0 (0%) Maximal mean placebo-subtracted QTcF 10.12 18.81 14.35 Maximal mean placebo-subtracted QTcB 9.24 15.54 17.22 ----------------------------------------------------------------------

Data from the study showed that the maximal mean placebo-subtracted QTcF change from baseline (dQTcF) for the standard dose of Neurodex is 10.12 msec at 3 hours and the upper bound of the one-sided 95% CI is 15.05 msec. The dQTcF for moxifloxacin is 14.35 msec at 1 hour and the lower bound of the one-sided 95% CI is 9.73 msec. There were no significant QTc outliers, and no patient in the study exceeded a QTcF greater than or equal to 480 msec or absolute change of greater than 60 msec. The magnitude of changes seen with Neurodex is predictable and consistent with changes seen for the reference standard, moxifloxacin.

About Neurodex

Neurodex is a combination of two well-characterized compounds, the active ingredient dextromethorphan, and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. The 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.

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, cardiovascular disorders, inflammation and infectious diseases. AVANIR currently markets FazaClo(R), the only orally-disintegrating formulation of clozapine for the management of severely ill schizophrenic patients who fail to respond adequately to standard schizophrenic drug treatments. FazaClo is also indicated for reducing the risk of suicidal behavior in patients with schizophrenic or schizoaffective disorder. For full prescribing information and important safety information regarding FazaClo, please visit www.fazaclo.com. AVANIR's lead product in development, Neurodex(TM) for the treatment of involuntary emotional expression disorder, is the subject of a New Drug Application under priority review with the FDA. Additionally, AVANIR has initiated a Phase III clinical trial with Neurodex as a potential treatment for patients with painful diabetic neuropathy. AVANIR has active collaborations with two international pharmaceutical companies: Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease and AstraZeneca for the treatment of cardiovascular disease. 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 Statement

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", "anticipate", "believe", "plan" or "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 Neurodex will receive regulatory approval; or that if such regulatory approval is received, AVANIR will be able to market Neurodex successfully. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are often unpredictable and outside the influence and/or control of the company. Risks and uncertainties 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 or obligation to update these forward-looking statements.

Source: Business Wire

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