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Flexeril Clinical Studies
Controlled clinical studies show that Flexeril (cyclobenzaprine HCl) significantly improves the signs and symptoms of skeletal muscle spasm as compared with placebo. The clinical responses include improvement in muscle spasm as determined by palpation, reduction in local pain and tenderness, increased range of motion, and less restriction in activities of daily living. When daily observations were made, clinical improvement was observed as early as the first day of therapy.
Eight double-blind controlled clinical studies were performed in 642 patients comparing Flexeril (cyclobenzaprine HCl), diazepam, and placebo. Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated. In three of these studies there was a significantly greater improvement with Flexeril (cyclobenzaprine HCl) than with diazepam, while in the other studies the improvement following both treatments was comparable.
Although the frequency and severity of adverse reactions observed in patients treated with Flexeril (cyclobenzaprine HCl) were comparable to those observed in patients treated with diazepam, dry mouth was observed more frequently in patients treated with Flexeril (cyclobenzaprine HCl) and dizziness more frequently in those treated with diazepam. The incidence of drowsiness, the most frequent adverse reaction, was similar with both drugs.
Analysis of the data from controlled studies shows that Flexeril (cyclobenzaprine HCl) produces clinical improvement whether or not sedation occurs.
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