FDA approves SOMA 250 mg

The Food and Drug Administration (FDA) has approved SOMA (carisoprodol) 250 mg
as a new recommended dose. SOMA is a skeletal muscle relaxant, indicated for
treatment of painful musculoskeletal conditions such as backache.
SOMA is a well-established brand in the US and the substance carisoprodol,
generates around 10 million prescriptions per year. 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.

The FDA approval of SOMA 250 mg was based on the results from 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. “The
clinical benefits of SOMA 250 mg 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, “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.”

For more information, please contact:

Anders Larnholt, Investor Relations, tel. +46 709 458 878

Meda AB
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FDA approves SOMA 250 mg

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