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FDA Approves SOMA(R) (carisoprodol) 250 mg
Date:9/17/2007

ick, President & Chief Executive Officer of MedPointe Pharmaceuticals. "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."

Clinical Trials Demonstrate SOMA 250 mg Efficacy and Favorable Tolerability 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 and MP505) which included more than 1,300 patients aged 18 to 65 who suffered from acute painful muscle spasm of the lower back. Results from both studies showed that SOMA 250 mg provided significant and rapid relief of back pain compared to placebo (P = 0.0001) with efficacy comparable to SOMA 350 mg.

Results from the studies also showed that SOMA 250 mg provided efficacy comparable 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 mg was 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 SOMA 250 mg in clinical trials included drowsiness (13%), dizziness (8%) and headache (5%). The most common side effects for SOMA 350 mg included drowsiness (17%), dizziness (7%) and headache (3%).

This new recommended dose of SOMA is 250 mg three times a day and at bedtime.

Important Information

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 mu
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SOURCE MedPointe Pharmaceuticals
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