The USFDA has approved dextromethorphan hydrobromide bupropion hydrochloride (HBr-bupropion HCl) for treating adults with major depressive disorder (MDD). To date, this is the only FDA-approved rapid-acting oral drug for treating MDD that has shown a statistically significant antidepressant efficacy compared to a placebo beginning in the first week. The FDA approval was given based on clinical trials where the rapid antidepressant effects of this drug were sustained at all subsequent time points.
These trials involved over 1100 patients with depression, notably the GEMINI placebo-controlled study and the ASCEND study (Table 1). Benefits of HBr-bupropion HCl Novel oral N-methyl-D-aspartate (NMDA) antagonist mechanism Rapid antidepressant efficacy A relatively favorable safety profile Recommendations for use in specific conditions Lactation: Not recommended Severe Renal Impairment: Avoid…
