Avanir Files IND for Pain Drug in MS

Avanir Pharmaceuticals, Inc. has filed an IND application with the FDA to begin a large Phase II trial of AVP-923, an investigational drug for the treatment of central neuropathic pain in patients with multiple sclerosis (MS).

The study will evaluate the safety, tolerability, and efficacy of three dose levels of AVP-923 capsules for the treatment of central neuropathic pain in MS patients. AVP-923 is a combination of dextromethorphan (DM) and quinidine (Q). The trial is a multicenter, randomized, double-blind, placebo-controlled, four-arm parallel group study. The primary efficacy endpoint is the Pain Rating Scale obtained from daily patient diaries. Secondary endpoints include measures of fatigue, disability, impact of MS on daily life, sleep quality, cognition and depression.

“Over half of MS patients suffer from chronic and debilitating pain, with a substantial negative impact on their quality of life. With no FDA-approved therapies to treat central neuropathic pain in MS patients, this represents an area of high unmet medical need,” said Randall Kaye, M.D., chief medical officer of Avanir Pharmaceuticals. “The team at Avanir has done an exemplary job of designing and developing a program to explore the potential of AVP-923 in MS-related pain as well as other important endpoints including fatigue, sleep quality and cognition. We are excited about the potential of this compound, which may ultimately represent a new approach to treating central neuropathic pain in MS patients.”