ALISO VIEJO, Calif., Nov. 3, 2011 /PRNewswire/ — Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the enrollment of the first patient in the PRIME study. The PRIME study is a Phase II clinical trial investigating the use of AVP-923 for the treatment of central neuropathic pain in patients with multiple sclerosis (MS).
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“With approximately 400,000 people in the U.S. suffering from MS, there is clearly a need for effective and safe therapies to treat symptoms associated with this disease such as central neuropathic pain,” said Andrew Goodman, MD, professor of neurology at the University of Rochester. “Neuropathic pain remains inadequately treated in many people with MS and significantly interferes with daily functioning of those affected.”
About the PRIME Study
The objectives of the PRIME (Pain Research In Multiple sclErosis) study are to evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment of central neuropathic pain in patients with multiple sclerosis. The trial is a multicenter, randomized, double-blind, placebo-controlled, 4-arm parallel group study. Eligible patients will receive one of 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 will be measured based on the Numeric Pain Rating Scale as recorded in patient diaries. Secondary assessments include measures of fatigue, impact of MS on daily life, sleep quality, cognition and depression. Safety will be assessed by monitoring adverse events, clinical laboratory tests, ECGs and physical examinations.
Avanir expects to enroll approximately 400 patients both in the U.S. and internationally.
“The initiation of this clinical study is an important step in the continued development of AVP-923,” said Joao Siffert, MD, senior vice president of research and development at Avanir. “With no approved therapies for central neuropathic pain in MS, we are very excited about the potential application of AVP-923 as a safe and effective option treatment option. In addition, we look forward to exploring the potential of AVP-923 across a broad range of other CNS disorders.”
About Multiple Sclerosis and Central Neuropathic Pain
Multiple sclerosis is an autoimmune demyelinating disease of the central nervous system (CNS) that causes abnormal function of the motor, sensory and visual systems. The initial disease course is often characterized by multiple exacerbations and remissions, with symptoms determined by the location and extent of the demyelinating areas in the brain and spinal cord. Chronic pain affects nearly half of all MS patients and has a substantial impact on daily life, further affecting their ability to function and work. MS patients experience pain of several types including musculoskeletal pain, painful tonic spasms and neuropathic pain, including trigeminal neuralgia, Lhermitte’s sign and central neuropathic pain affecting the limbs. Central neuropathic pain is caused by lesions of sensory pathways in the brain and spinal cord and is estimated to affect approximately 30% of MS patients. It is characterized by moderate to severe painful sensations of burning, pricking, electric shocks and squeezing overlying areas of numbness. Common analgesics provide inadequate relief and there are no FDA-approved drugs for the treatment of central neuropathic pain.
