Lower safer dose of Soma approved by FDA

Implications: As a pharmaceutical consultant working in pain management area, I think lower dose will offer similar efficacy as Soma 350 mg but with a more favorable tolerability profile. Last week, Last week, The Food and Drug Administration (FDA) have approved 250 mg (lower dose) of Soma (carisoprodol) for treatment of painful musculoskeletal conditions such as backache. As a pharmaceutical consultant working in pain management area, I think lower dose will offer similar efficacy as Soma 350 mg but with a more favorable tolerability profile. FDA approved lower dose based on two randomized, double-blind, placebo-controlled, multi-site parallel group studies which have been ongoing for several years and included more than 1,300 patients. I think Soma is a well-established brand and generates around 10 million prescriptions per year. Soma 250mg is granted a minimum 3 year exclusivity period in the US.

Analysis: As a pharmaceutical consultant working in pain management area, I think lower dose will offer similar efficacy as Soma 350 mg but with a more favorable tolerability profile.

Last week, The Food and Drug Administration (FDA) have approved 250 mg (lower dose) of Soma (carisoprodol) for treatment of painful musculoskeletal conditions such as backache. Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax tense skeletal muscles in man. The mode of action of carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. FDA approved lower dose based on two randomized, double-blind, placebo-controlled, multi-site parallel group studies which have been ongoing for several years and included more than 1,300 patients. I think Soma is a well-established brand in the US and the substance carisoprodol generates around 10 million prescriptions per year. Average daily cost of Soma is about $7 daily based on online information. Soma 250 mg is now the only available low-dose treatment of carisoprodol that can offer similar efficacy as Soma 350 mg but with a more favourable tolerability profile. Soma 250mg is granted a minimum 3 year exclusivity period in the US. The launch will start immediately.