Soma 250mg dose gets approval

The 250mg dose will be the lowest carisoprodol treatment available, which has been marketed since 1959.

The previous recommended dose was 350mg, which is used in the treatment of painful musculoskeletal conditions such as backache through the action of working as a skeletal muscle relaxant.

"The clinical benefits of Soma 250mg are in line with current treatment strategies for back pain which focuses on helping patients to return to normal physical activity as quickly as possible," lead author and investigator for the Soma 250mg clinical trials Lee Ralph said in a statement.

"I look forward to offering my patients Soma 250mg as data indicates that it can help relieve discomfort from acute backache," said Ralph, who is an assistant clinical professor at the University of California's department of family and preventative medicine.

The FDA approval was based on the results of two randomised, double-blind, placebo-controlled, multi-site parallel group studies involving more than 1,300 patients over several years.

The Soma 250mg dose has been shown to offer similar efficacy as Soma 350mg

but with a more favourable tolerability profile.

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

MedPointe Pharmaceuticals, the U.S. subsidiary of Meda AB, president and chief executive Paul Edick said in a statement: "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."

Soma 250mg is granted a minimum three-year exclusivity period in the US, with the launch of the product starting immediately.

Carisoprodol is marketed in the UK and other countries as Sanoma and Carisoma.

Back pain is the fifth leading reason for patient visits to physicians and ranks among the top ten most costly physical disorders.

This ailment is responsible for direct health care expenditures of more than $20 billion annually and as much as $50 billion per year when indirect costs are included.

Soma generates about 10 million prescriptions a year.

A fortnight ago, Meda AB signed a license and supply agreement with BioDelivery Sciences International (BDSI) for the commercialisation rights to BDSI's BEMA Fentanyl oral adhesive disc in the US, Canada and Mexico.