New Dose For Old Drug

Implications: The FDA recently approved a 250mg Soma® tablet manufactured by MedPointe Pharmaceuticals as a new recommended dose for the treatment of painful musculoskeletal problems such as backache. The drug is not new, in fact it has been around for nearly 50 years, first receiving FDA approval in 1959. The same drug was available at one time in a 250mg capsule but was discontinued.

Analysis: The approval of Soma® 250mg tablets does not strike me as a significant event in the treatment of musculoskeletal problems nor does it seem to offer any significant clinical benefit over existing products.

Carisoprodol and its metabolite meprobamate have been available for decades for use in the treatment of musculoskeletal problems. Carisoprodol is currently available in a 350mg tablet.

The use of both carisoprodol and meprobamate has been limited due their side effect profiles, including potential physical and/or psychological dependence. Although the drug is only indicated for "relief of discomfort associated with acute, painful musculoskeletal conditions in adults," and should only be used for up to 2 to 3 weeks, it is the experience of this practitioner that it is often prescribed for much longer periods of time and has a propensity for causing dependence.

With multiple other effective options available, I see little or no advantage in the use of this new product.