The Food and Drug Administration or FDA recently approved 250 mg of SOMA (carisoprodol) to relieve pain and discomfort associated with acute musculoskeletal conditions such as backaches. SOMA 250 mg is just as effective as the widely prescribed 350 mg dose of the muscle relaxant. However, the lower dosage is more easily tolerable and results in fewer side effects such as drowsiness. The SOMA 250 mg prescription will be available as of September 2007.

Back pain is one of the top ten most expensive physical disorders. It is also the fifth leading cause of doctor visits. The problem costs more than $20 billion every year in direct health expenditures and up to $50 billion annually when you factor indirect costs.

Lee Ralph, M.D. and Assistant Clinical Professor of the University of California’s Department of Family and Preventative Medicine explains the benefits: “The clinical benefits of SOMA 250 mg are in line with current treatment strategies for back pain which focus on helping patients to return to normal physical activity as quickly as possible.” LaJolla, a physician partner at the San Diego Sports Medicine and Family Health Center and one of the main investigators for the SOMA 250 mg clinical trials echoes this sentiment: “I look forward to offering my patients SOMA 250 mg as data indicates that it can help relieve discomfort from acute backache. Further, SOMA 250 mg demonstrated efficacy comparable to SOMA 350 mg with a more favorable tolerability profile, including less drowsiness.” Paul R. Edick, President & Chief Executive Officer of MedPointe Pharmaceuticals also praises SOMA 250 mg: “The availability of SOMA 250 mg marks a significant milestone in the treatment of acute backache, a common and terribly painful condition which also has a tremendous economic impact on our nation’s health care system. While SOMA has a long history in the treatment of discomfort associated with acute, painful musculoskeletal conditions with nearly 50 years on the market, we are pleased to provide a new recommended dose that provides a proven clinical benefit to help relieve the burden of these conditions.”

The FDA approved SOMA 250 mg after reviewing the results of two random, placebo-controlled double-blind multi-site parallel group studies (MP502 & MP505) that included more than 1,300 individuals 18 to 65 who suffered acute muscle spasms of their lower back. SOMA 250 mg proved to offer quick and significant relief of back pain, when compared to the placebo (P=0.0001) comparable to SOMA 350 mg.

The study also revealed that SOMA 250 mg was just as effective as SOMA 350 mg, but was more widely tolerated which meant less people had to stop using the treatment because of related adverse effects. The discontinuation rate for SOMA 250 mg was similar to the placebo and lower than the patients who took SOMA 350 mg (2%, 2.7% & 5.4% respectively). The most common side effects of the SOMA 250 mg trials were drowsiness (13%), dizziness (8%) and headaches (5%). The SOMA 350 mg side effects included drowsiness (17%), dizziness (7%) and headaches (3%). Doctors recommend the new SOMA dose of 250 mg taken three times daily and at bedtime.

Important Information

SOMA (carisoprodol) is effective for providing pain relief for adults who suffer from acute musculoskeletal conditions. However, SOMA should only be used for short periods of 2 to 3 weeks because the effectiveness of prolonged use has not yet been proven. Fortunately, acute painful musculoskeletal conditions usually last for only short periods of time.

Anyone who takes SOMA in combination with psychotropic drugs or CNS depressants such as alcohol should be very cautious. They can be addictive, and certain patients have experienced withdrawal, abuse and dependence with long-term use of the drug. Patients prone to addiction should discuss the situation thoroughly with their doctor before taking SOMA. Reports have also revealed seizures in some patients treated with SOMA, although most of the cases were associated with an overdose of multiple drugs.