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Avanir Pain Combo Misses Endpoints

Placebo response wipes out effectiveness signal in MS trial

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Avanir Pharmaceuticals has reported that its Phase II clinical trial of the investigational drug AVP-923 (dextromethorphan / quinidine) for the treatment of central neuropathic pain in patients with multiple sclerosis did not meet the primary efficacy endpoint.

In the study, AVP-923 treated patients experienced levels of pain reduction commensurate with those observed in similar studies and the improvement in pain scores from baseline reached statistical significance; however, there was no difference between the treatment arms and placebo. A higher than expected placebo response may have negatively impacted the study results, according to a company statement. The treatment was generally safe and well tolerated.

The company plans to review the detailed data from the study in conjunction with previously generated data in diabetic peripheral neuropathic pain to determine next steps for the development of AVP-923 in neuropathic pain.

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