FDA News

MedPointe's SOMA Gets FDA Approval

(Sept 17, 2007)-- MedPointe Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved SOMA (carisoprodol) 250 mg as a new recommended dose of SOMA for the relief of discomfort associated with acute, painful musculoskeletal conditions, such as backache. SOMA 250 mg offers comparable efficacy to the widely prescribed skeletal muscle relaxant SOMA 350 mg with a more favorable tolerability profile, including less drowsiness. SOMA 250 mg will be available by prescription nationwide immediately.

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.

"The clinical benefits of SOMA 250 mg are in line with current treatment strategies for back pain which focus on helping patients to return to normal physical activity as quickly as possible," said Lee Ralph, M.D., Assistant Clinical Professor, Department of Family and Preventative Medicine, University of California, San Diego, LaJolla; physician partner, San Diego Sports Medicine and Family Health Center; and a lead author and investigator for the SOMA 250 mg clinical trials. "I look forward to offering my patients SOMA 250 mg as data indicates that it can help relieve discomfort from acute backache. Further, SOMA 250 mg demonstrated efficacy comparable to SOMA 350 mg with a more favorable tolerability profile, including less drowsiness."

"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," said Paul R. Edick, 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."

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