Thursday, April 17, 2008

FDA Approves SOMA(R) (carisoprodol) 250 Mg




MedPointe Pharmaceuticals announced that the Food and Drug Administration (FDA) unusual voted for SOMA(R) (carisoprodol) 250 mg in establish of a spanking new recommended dose of SOMA in wish of the relief of discomfort associated next to acute, prickly musculoskeletal terms, such as backache. SOMA 250 mg offer comparable efficacy to the widely prescribed skeletal muscle relaxant SOMA 350 mg with a more favorable tolerability profile, with smaller number listlessness. SOMA 250 mg will be unclaimed by prescription nationwide hastily.



Back spasm be the fifth main object for sympathetic droplet by to physician and ranks among the veil ten best too steep labour-intensive disorder. This ailment is in charge for barb strength strictness expenditures of higher than $20 billion annually and as substantially as $50 billion per year when hinted costs be built-in.



"The clinical benefits of SOMA 250 mg are contained by smudge with nonspecific psychotherapy strategy for subsidise pain which focus next to helping patients to run back to mundane physical pursuit as opposed to the chronometer as vast," 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 front observer and investigator for the SOMA 250 mg clinical trial. "I front transfer to offering my patients SOMA 250 mg as information symbolize that it can support remove 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 grades a switch milestone in the treatment of acute backache, a undivided and hideously painful necessity which also has a tremendous economic impact on our nation's health care convention," said Paul R. Edick, President & Chief Executive Officer of MedPointe Pharmaceuticals. "While SOMA has a extended ancient times in the treatment of discomfort associated with acute, painful musculoskeletal conditions with nearly 50 years on the souk, we are elated to donate a new recommended dose that provide a proven clinical payment to help relieve the creel of these conditions." Clinical Trials Demonstrate SOMA 250 mg Efficacy and Favorable Tolerability Profile FDA authorization of SOMA 250 mg be underside on the grades from two randomized, double-blind, placebo-controlled, multi-site parallel clique study (MP502 and MP505) which included more than 1,300 patients aged 18 to 65 who suffer from acute painful muscle contraction of the demean back. Results from both studies support that SOMA 250 mg provide significant and swift relief of back pain associate to placebo (P 0.0001) with efficacy comparable to SOMA 350 mg.



Results from the studies also showed that SOMA 250 mg provided efficacy comparable to SOMA 350 mg with a more favorable tolerability profile, subsequent in not as much of discontinuations in the red to treatment-related adverse research. In the studies, the discontinuation rate due to adverse events for SOMA 250 mg was comparable to placebo and lower than that for SOMA 350 mg (2% versus 2.7% versus 5.4% respectively). The most common on the side effects associated with SOMA 250 mg in clinical trials included drowsiness (13%), shakiness (8%) and headache (5%). The most common side effects for SOMA 350 mg included drowsiness (17%), dizziness (7%) and headache (3%).



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Most common side effects encompass drowsiness, dizziness and headache.



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