Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Avanir Pharmaceuticals has announced the safety and efficacy results from the Phase III trial of AVP-923 in treating diabetic neuropathic pain.
Subscribe to our email newsletter
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.