Avanir Pharmaceuticals Announces Publication of Phase III Study Results Showing Efficacy and Safety Print E-mail
By Staff and Wire Reports   
Wednesday, 08 February 2012 09:47
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced today that the results of the study entitled "Efficacy and Safety of Dextromethorphan/Quinidine (AVP-923) at Two Dosage Levels for Diabetic Neuropathic Pain: A Double-Blind, Placebo-Controlled, Multicenter Study" have been published in the February edition of the journal Pain Medicine.
"Throughout a 13-week trial, AVP-923 was effective, with an acceptable safety profile, for treatment of diabetic peripheral neuropathic pain. The findings indicate that other fixed-dose combinations of AVP-923 should be studied to improve overall tolerability while maintaining significant efficacy," said Aziz Shabaini, MD, Medical Director of the Nerve and Muscle Center, Texas.

AVP-923 is a combination of dextromethorphan (DM) and quinidine (Q). AVP-923 is currently being studied in a Phase II clinical trial (the PRIME study) in central neuropathic pain in patients with multiple sclerosis.

"Today's publication in a leading peer-review medical journal complements a body of scientific literature suggesting that dextromethorphan could be efficacious in neuropathic pain," said Joao Siffert, MD, senior vice president of research and development at Avanir. "These results provide additional rationale in support of the ongoing PRIME study, which is evaluating the combination of dextromethorphan and quinidine in central neuropathic pain in patients with multiple sclerosis."

AVANIR Pharmaceuticals' Xenerex HuMAB Technology is used to develop human monoclonal antibodies for the treatment of infectious diseases and other therapeutic applications. The proprietary technology provides a platform for accessing human monoclonal antibodies against disease relevant antigens. Its Xenerex technology is capable of generating fully human antibodies to target antigens and draws on the natural diversity of the human donor population.

AVANIR Pharmaceuticals' products and product candidates address therapeutic markets that include central nervous system disorders, inflammation and infectious disease. The company's product pipeline includes: Abreva® Docosanol 10% cream is a topical treatment for recurrent episodes of cold sores or fever blisters; NUEDEXTA is a combination product containing dextromethorphan hydrobromide and quinidine sulfate indicated for the treatment of pseudobulbar affect (PBA); AVP-923, an NMDA antagonist and sigma-1 agonist, in diabetic peripheral neuropathic pain; etc.

In the 13-week, phase III, randomized, controlled trial, 379 adults with daily symmetric diabetic peripheral neuropathy (DPN) leg pain for >3 months received double-blind placebo, DMQ 45/30 mg, or DMQ 30/30 mg, administered once daily for 7 days and twice daily thereafter. Efficacy measures included four pain rating scales applied daily using patient diaries, and another two applied at five clinic visits.  Safety and tolerability were assessed by adverse event reports, physical examination, electrocardiogram and clinical laboratory tests. Patients with certain cardiac conditions were excluded from the study along with patients taking certain medications.

On all six scales, DMQ 45/30 mg was significantly superior to placebo, including the primary efficacy analysis, which utilized mixed-effects modeling to test all scores on an 11-point numerical Pain Rating Scale (p < 0.0001). Sensitivity analyses gave consistent results.



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