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Avanir Pharmaceuticals Announces Publication of Phase III Study Results Showing Efficacy and Safety of AVP-923 in the Treatment of Diabetic Neuropathic Pain
Date:2/8/2012

er 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.

Study Results

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. Efficacy versus placebo was also seen for diary ratings of present pain intensity, and pain interference with sleep and with activities (all p < 0.0001). Among clinic-visit assessments, DMQ 45/30 mg demonstrated greater leg-pain relief (p = 0.0002) and greater reduction of leg-pain intensity (p = 0.0286) versus placebo. The efficacy of DMQ 30/30 mg was numerically less than for 45/30 mg but for most outcomes remained significantly greater versus placebo. Adverse events were mostly mild or moderate and of expected types. Discontinuation for adverse events in the DMQ groups was at least twice as common as placebo.

About Diabetic Peripheral Neuropathic Pain

Diabetic neuropathic pain, one of the most debilitating forms of pain, is caused by nerve damage that can result from diabetes. It is often described as burning, tingling, stabbing, or pins and needles in the feet, legs, hands or arms. The most frequent form, estimated to affect approximately 50% of diabetic patients, is a distal symmetric polyneuropathy that can involve both small and large sensory fibers. The associated pain, estimated to affect approximately 25% of DPN patients, can be severe and disabling.

About AVP-923

AVP-923 is a combination of two well-characterized compounds: the active ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagoni
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SOURCE Avanir Pharmaceuticals, Inc.
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