AVP-923 combines dextromethorphan hydrobromide and low dose quinidine sulfate, and is currently being investigated in a Phase II clinical trial in central neuropathic pain in patients with multiple sclerosis.
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" has enrolled 379 adults with daily symmetric diabetic peripheral neuropathy (DPN) leg pain for more than three months.
In a 13-week Phase III randomized controlled trial subjects were given DMQ 45/30 mg, or DMQ 30/30 mg, once daily for 7 days and twice daily later.
The study evaluated efficacy, safety and tolerability measures by assessing adverse event reports, physical examination, electrocardiogram and clinical laboratory tests.
Following 13-week trial, DMQ 45/30 mg showed greater leg-pain relief and greater reduction of leg-pain intensity compared to placebo.
Nerve and Muscle Center, Texas medical director Aziz Shabaini said AVP-923 was found effective, with an acceptable safety profile, for the 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," Shabaini added.