San Diego, Calif., November 14, 2006 -- Avanir Pharmaceuticals (NASDAQ: AVNR) announced today that the Company has enrolled the targeted number of patients needed to assess the efficacy endpoint in its ongoing Zenvia Phase III painful diabetic neuropathy trial.
The protocol for the Phase III study was reviewed by the U.S. Food and Drug Administration (FDA) through a special protocol assessment (SPA) process. An SPA is an agreement between the FDA and the sponsor of a clinical trial documenting that if the study endpoints are met, the results should be acceptable to support a New Drug Application (NDA). Assuming positive outcomes, Avanir currently expects to use the data from this study as one of the pivotal Phase III clinical trials required before it would be able to submit an NDA for this indication.
"In the statistical plan, a total of 364 patients would be required to obtain 90% power with a 30% allowance for drop out," said Randall Kaye M.D., Vice President of Clinical and Medical Affairs for Avanir "We have determined that it is unnecessary to enroll additional patients and now consider the trial fully enrolled with approximately 380 patients. The data from the trial is currently anticipated in mid-2007."
Painful diabetic neuropathy may affect more than 50% of patients with diabetes as their disease progresses, according to the American Diabetes Association. The damaged nerves can alter the sensitivity of pain centers in the spinal cord and consequently intensify pain transmission within the central nervous system. Symptoms of painful diabetic neuropathy may include numbness or insensitivity to pain or temperature, a tingling, burning, or prickling sensation, sharp pains or cramps, extreme sensitivity to touch, and loss of balance and coordination.
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®, 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. Zenvia™, Avanir's lead product candidate for the treatment of involuntary emotional expression disorder (IEED), is the subject of an approvable letter from the FDA and future development plans for this product candidate are under consideration. The Company does not know at this time what impact, if any, the ongoing discussions with the FDA for IEED may have on the development of Zenvia for other indications. Additionally, Avanir has completed the patient recruitment in a Phase III clinical trial with Zenvia 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®, 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", "intend", "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 the Company will continue the clinical development of Zenvia after its planned meeting with the FDA or that Zenvia will receive FDA regulatory approval for any indication. There can also be no assurance that the FDA will not require additional evidence of Zenvia's safety and/or efficacy, notwithstanding the existence of an SPA for the Company's neuropathic pain clinical trials. If regulatory approval is received, there can be no assurance that AVANIR will be able to market Zenvia successfully. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are often unpredictable and outside the influence and 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, in the Company's Current Report on Form 8-K filed with the SEC on November 3, 2006, 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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