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."
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