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taj pharma Bupropion HCl

HOME >> API >> API List1 >> Bupropion HCl >> Clinical Pharmalogy

CLINICAL PHARMALOGY
Bupropion HCl CAS Number: 31677-93-7

Bupropion has been shown to be effective in the treatment of major depressive disorder in numerous double-blind controlled trials. Efficacy has been demonstrated relative to placebo in both inpatients and out-patients.
Additionally, in comparative studies, bupropion has been found to have efficacy comparable to other antidepressants Seven studies employed an SSRI as the active control (references 21–26 and data on file, GlaxoSmithKline, Research Triangle Park, N.C.), and 4 of these also included a placebo control

Longer-term efficacy was demonstrated in a 1-year relapse-prevention study in which patients who had responded to 8 weeks of therapy with bupropion SR (150 mg b.i.d.) were randomly assigned in a double-blind manner to either continue therapy with active medication or switch to placebo

Using survival analysis, bupropion separated statistically from placebo, demonstrating that maintenance treatment with bupropion prevents relapse. In fact, by study end, the odds of relapsing for subjects in the placebo group were almost twice that seen in subjects in the bupropion group. Median time to relapse was greater than 44 weeks for bupropion compared to 24 weeks for placebo.

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