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Back pain is the fifth leading reason for patient visits to physicians andranks among the top ten most costly physical disorders. This ailment isresponsible for direct health care expenditures of more than $20 billionannually and as much as $50 billion per year when indirect costs are included.
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"The clinical benefits of SOMA 250 mg are in line with current treatmentstrategies for back pain which focus on helping patients to return to normalphysical activity as quickly as possible," said Lee Ralph, M.D., AssistantClinical Professor, Department of Family and Preventative Medicine, Universityof California, San Diego, LaJolla; physician partner, San Diego SportsMedicine and Family Health Center; and a lead author and investigator for theSOMA 250 mg clinical trials. "I look forward to offering my patients SOMA 250mg as data indicates that it can help relieve discomfort from acute backache.Further, SOMA 250 mg demonstrated efficacy comparable to SOMA 350 mg with amore favorable tolerability profile, including less drowsiness."
"The availability of SOMA 250 mg marks a significant milestone in thetreatment of acute backache, a common and terribly painful condition whichalso has a tremendous economic impact on our nation's health care system,"said Paul R. Edick, President & Chief Executive Officer of MedPointePharmaceuticals. "While SOMA has a long history in the treatment ofdiscomfort associated with acute, painful musculoskeletal conditions withnearly 50 years on the market, we are pleased to provide a new recommendeddose that provides a proven clinical benefit to help relieve the burden ofthese conditions."
Clinical Trials Demonstrate SOMA 250 mg Efficacy and FavorableTolerability Profile
FDA approval of SOMA 250 mg was based on the results from two randomized,double-blind, placebo-controlled, multi-site parallel group studies (MP502 andMP505) which included more than 1,300 patients aged 18 to 65 who suffered fromacute painful muscle spasm of the lower back. Results from both studiesshowed that SOMA 250 mg provided significant and rapid relief of back paincompared to placebo (P = 0.0001) with efficacy comparable to SOMA 350 mg.
Results from the studies also showed that SOMA 250 mg provided efficacycomparable to SOMA 350 mg with a more favorable tolerability profile,resulting in fewer discontinuations due to treatment-related adverse events.In the studies, the discontinuation rate due to adverse events for SOMA 250 mgwas comparable to placebo and lower than that for SOMA 350 mg (2% versus 2.7%versus 5.4% respectively). The most common side effects associated with SOMA250 mg in clinical trials included drowsiness (13%), dizziness (8%) andheadache (5%). The most common side effects for SOMA 350 mg includeddrowsiness (17%), dizziness (7%) and headache (3%).
This new recommended dose of SOMA is 250 mg three times a day and atbedtime.
Important Information
SOMA (carisoprodol) is indicated for the relief of discomfort associatedwith acute, painful musculoskeletal conditions in adults. SOMA should be usedfor short periods (up to two or three weeks) because adequate evidence ofeffectiveness for more prolonged use has not been established and becauseacute, painful musculoskeletal conditions are generally of short duration.
Since the effects of SOMA and CNS depressants (in
