AVANIR Announces Publication of Phase II Diabetic Neuropathic Pain Trial Results
San Diego, Calif., October 17, 2006 – Avanir Pharmaceuticals (NASDAQ: AVNR) announced today that results of a Phase II clinical trial evaluating escalating doses of Neurodex™ in the treatment of painful diabetic neuropathy were published for the first time in the October issue of Clinical Therapeutics (Vol 28, Number 10, 2006). The published article "Dextromethorphan and Quinidine in Adult Patients with Uncontrolled Painful Diabetic Peripheral Neuropathy: A 29-Day, Multicenter, Open-Label, Dose-Escalation Study" indicates that the investigational new drug was well tolerated up to the highest target dose (60 mg dextromethorphan and 60 mg of quinidine dosed twice per day).
The open label trial, conducted at five U.S. sites in 36 patients with painful diabetic neuropathy, assessed the safety and tolerability of Neurodex, a proprietary formulation of dextromethorphan (DM) and low dose quinidine (Q). A preliminary assessment of the drug candidate's efficacy in the treatment of painful diabetic neuropathy was obtained using pain ratings scales and patient diaries. At the end of the study, mean changes from baseline using Pain Intensity Rating Scale and the Pain Relief Rating Scale scores were highly statistically significant (p<0.001). Daily patient diary assessments also demonstrated statistically significant improvements in sleep, present pain intensity, activity and pain rating scales (p<0.001 in each case).
Adverse events related to Neurodex were mild to moderate and were consistent with the previously known effects of the drug. Adverse events reported included nausea, dizziness and headache. Three patients did not complete the study, two due to adverse events and one due to inability to comply with the protocol. Ninety-two percent of participants completed the study, and 70% of the subjects that completed the study tolerated the maximum allowed dose (60DM/60Q dosed twice per day).
"We are very pleased that this important work has been published. We believe that Neurodex has the potential to be an important therapy in this area and we are looking forward to the results from our ongoing Phase III study in mid-2007," noted Randall Kaye, M.D., Vice President of Medical Affairs of Avanir.
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 a binding 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 expects the current study will be the first of two Phase III clinical trials that likely will be needed before submitting an NDA for this indication.
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. Avanir 's lead product candidate, Neurodex™ 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®, 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.
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|Oct 17, 2006|