In the news release, SOMA 250 MG Shown To Significantly Improve Functionality and Reduce Disability in Patients With Low Back Pain in Three Days, issued Feb. 3, 2010 by MEDA AB over PR Newswire, we are advised by a representative of the company that under the subheading "Important Information About SOMA® 250 mg", the first sentence of the third paragraph should read "Since the effects of SOMA and CNS
SOMERSET, N.J., Feb. 3 /PRNewswire/ -- A recent analysis of two pivotal clinical trials in patients with acute low back pain (ALBP) who were treated with SOMA® (carisoprodol) 250 mg showed significantly improved functionality and reduced disability after three days of treatment, as measured by the Roland-Morris Disability Questionnaire (RMDQ). This analysis is being presented this week at the 26th annual meeting of the American Academy of Pain Medicine in San Antonio, TX. In addition, a recent review of published literature indicates that SOMA 250 mg is the only skeletal muscle relaxant proven to significantly improve functionality in patients with acute low back pain as measured by the RMDQ. SOMA 250 mg is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions.
"This outcomes data differentiates SOMA 250 mg among the diverse treatment choices for patients with acute low back pain," said Steven M. Simon, MD, RPh, Clinical Assistant Professor, University of Kansas and Kansas City, University of Medicine and Biosciences. "Almost all acute low back pain is mechanical in origin and one in five patients with this condition suffers from significant limitations in activity. Treatment of acute low back pain with SOMA 250 mg has been shown to improve functionality, as measured by an internationally validated tool, and it may be a useful treatment option for many patients suffering from this common condition."
Low back pain can be a disabling condition that affects patients' ability to function. Patients with acute low back pain may walk more slowly, sleep less, avoid common activities, and stay home.
Outcomes-based healthcare is a comprehensive and increasingly popular approach to healthcare with goals of providing high quality care, controlling costs, and maximizing health care value based upon clinical quality and outcomes data. This approach is increasingly influencing decisions on selection of treatment regimens, prescribing and reimbursement. Promptly helping patients achieve clinical improvement in their functional status following acute musculoskeletal injuries is considered a key component of effective treatment and risk control strategies, and may contribute to a reduction in total healthcare costs.
"Overall, the greatest cost savings from a societal perspective may be obtained from interventions that promote early return to work and minimize lost productivity," said Al Moorad, MD, Medical Director, Integris Jim Thorpe Rehabilitation, Oklahoma City. "This may be accomplished by appropriate drug utilization to allow patients to actively participate in rehabilitation therapy and return to daily activities."
SOMA 250 mg Outcomes Data
SOMA 250 mg was studied in two multi-center, double-blind placebo-controlled clinical trials of more than 1300 subjects. In these studies, the co-primary endpoints were met: patients receiving SOMA 250 mg reported a statistically significant improvement in global impression of change and relief from starting backache on day 3, the primary analysis, compared to placebo (P<0.0001).
In these same studies, a secondary endpoint of patient functionality was measured. Patients achieved significantly greater clinical improvement in functionality outcomes as measured by the Roland-Morris Disability Questionnaire (RMDQ) with SOMA 250 mg vs. placebo on day 3. The Roland Morris Disability Questionnaire (RMDQ) is an internationally validated standard for measuring the degree of disability and functionality in patients with lower back pain. Developed in 1982 by Martin Roland and Richard Morris, the instrument is a sensitive and reliable self-evaluation tool. It is used as a marker to assess broader clinical impact of treatment modalities for patients with low back pain. Its ability to assess degree of pain at different points during treatment enables physicians to monitor patient improvement over time. The questionnaire contains 24 true/false statements regarding the effect of back pain on daily activities, adding one point per affirmative answer to the patient's total score. Its simplicity and sensitivity continue to make the RMDQ a standard assessment of back pain today.
SOMA 250 mg improved functionality as demonstrated by lower RMDQ scores compared to placebo (31% and 17% respectively). According to published recommendations by Ostelo et. al in the journal Spine in 2008, a greater than 30 percent reduction in RMDQ score from baseline represents a clinically meaningful improvement. Patients treated with SOMA 250 mg reported this level of improvement after 3 days of treatment.
Musculoskeletal Back Pain
Back pain is the fifth leading reason for patient visits to physicians and ranks among the top ten most costly physical disorders. Up to 85 percent of people suffer at least one bout of low back pain during their lifetime. Approximately 28 percent of the U.S. workforce experience disabling low back pain at some time, and 8 percent of the entire working population will be disabled in any given year, contributing to 40 percent of all lost work days. Among individuals with acute work-related back pain, high pain and disability, low recovery expectations, and fears that work may increase pain or cause harm are risk factors for chronic work disability.
The goals of therapy for acute low back pain include early intervention, reducing discomfort, eliminating muscle spasm, improving quality of life and maximizing patients' functionality. While analgesic pain management may be used to control the processes that underlie acute pain, relief may also require alleviation of muscle spasm with skeletal muscle relaxants in order to disrupt the spasm-pain-spasm progression of back pain. Non-pharmacologic approaches to promote healing also include early exercise and return to normal activities within sensible limits and with modifications as needed.
Important Information About SOMA® 250 mg
SOMA® (carisoprodol) is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. SOMA should be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration.
SOMA is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. Patients should be advised that SOMA may cause drowsiness and/or dizziness and has been associated with motor vehicle accidents. Patients should be advised to avoid using SOMA before engaging in potentially hazardous activities.
Since the effects of SOMA and CNS depressants (including alcohol) or psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously. In postmarketing experience with SOMA, cases of dependence, withdrawal, and abuse have been reported with prolonged use. SOMA should be used with caution in addiction-prone patients. There have been postmarketing reports of seizures in SOMA treated patients with most cases having occurred in the setting of multiple drug overdoses. Most common side effects include drowsiness, dizziness and headache.
Complete prescribing information about SOMA® 250 mg can be obtained by visiting www.soma250.com.
For more information on SOMA 250 mg, contact Mike Beyer, Sam Brown Inc. at [email protected] or (773) 463-4211.
For financial and company information, contact Anders Larnholt, VP Corporate Development & Investor Relations at [email protected] or +46 709 458 878.
MEDA AB (publ) is a leading international specialty pharma company. Meda's products are sold in 120 countries worldwide and the company is represented by its own organizations in 50 countries. The Meda share is listed under Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. To find out more, visit www.meda.se.
SOURCE MEDA AB
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