400-Patient International Phase 2 Clinical Trial to Begin in 2011
ALISO VIEJO, Calif., April 4, 2011 /PRNewswire/ — Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a large Phase II clinical trial of AVP-923, an investigational drug for the treatment of central neuropathic pain in patients with multiple sclerosis (MS). The FDA has acknowledged receipt of the submission and the company expects that the IND filing will be subject to standard 30-day review.
“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, MD, 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.”
“This marks the third IND for the NUEDEXTA/AVP-923 program and demonstrates our belief that the dual sigma-1 receptor agonist and NMDA receptor antagonist binding profile has significant potential beyond PBA,” said Keith A. Katkin, President and CEO of Avanir Pharmaceuticals. “In addition, we intend to file another IND within the next year to begin studying the potential use of AVP-923 in other forms of emotional lability – specifically anger, irritability, and other behavioral symptoms of dementia.”
About the Study
The objectives of the study are to evaluate the safety, tolerability, and efficacy of three dose levels of AVP-923 capsules for the treatment of central neuropathic pain in a population of patients with multiple sclerosis. AVP-923 is a combination of dextromethorphan (DM) and quinidine (Q). The trial is a multicenter, randomized, double-blind, placebo-controlled, 4-arm parallel group study. Eligible patients will be randomized to receive one of the three dose levels of AVP-923 containing either 45mg DM/10 mg Q, 30mg DM/10mg Q, 20mg DM/10mg Q or placebo, daily for 12 weeks. 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. Safety will be assessed by monitoring adverse events, clinical laboratory tests, ECGs, physical examinations, and vital signs.
The filing of this IND represents the next step in Avanir’s plan to broadly develop AVP-923 for conditions of the central nervous system (CNS). Avanir expects to enroll approximately 400 patients at 65 centers both in the US and internationally. The company anticipates enrolling the first patient into the trial before the end of 2011.
About Multiple Sclerosis and Central Neuropathic Pain
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