Lower dose of carisoprodol gets FDA nod

September 19, 2007

New dose of carisoprodol (Soma) is approved for MedPointe Pharmaceuticals

A 250-mg dose of carisoprodol is equally efficacious as the 350-mg tablet, according to manufacturer MedPointe Pharmaceuticals. MedPointe recently received FDA approval to market the new lower dose. The agency nod was based on review of two clinical trials. The trials showed that carisoprodol 250 mg was superior to placebo and as effective as the 350-mg formulation, with a favorable tolerability profile resulting in fewer discontinuations due to treatment-related adverse events. According to MedPointe, the 250-mg strength will be available by prescription nationwide immediately. Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults and is recommended for short-term use (up to two to three weeks).

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