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Extended-Release of Bupropion Hydrobromide (Aplenzin®) Compared to Bupropion Hydrochloride in Treatment Resistant Major Depressive Disorder

Maxwell Zachary Price1*, Richard Louis Price 2

Objectives: Extended-release (XL) bupropion hydrochloride (HCl) received FDA approval for Major Depressive Disorder (MDD) in 2003 and for Seasonal Affective Disorder (SAD) in 2006. XL bupropion hydrobromide (HBr) (Aplenzin^®) received FDA approval in 2008 for both MDD and SAD following demonstration of pharmacokinetic bioequivalence to XL bupropion HCl. However, no human clinical efficacy trials of XL bupropion HBr have been completed and none comparing it to XL bupropion HCl. We wanted to compare equivalent FDA-approved dosing of XL bupropion HBr to generic XL bupropion HCl in patients with Treatment-Resistant Depression (TRD).

Methods: We obtained informed consent from each patient prior to conducting a retrospective chart review on 30 adult patients with TRD (18 females, 12 males) who directly switched from their maximally tolerated dose of generic XL bupropion HCl, due to inadequate response and/or side effects, to an equivalent dose of XL bupropion HBr.

Results: Patients had a mean age of 38.7+14.7 years, had failed a mean of 4+2 antidepressants, and had a mean baseline PHQ-9 score of 20.9+4.3 prior to taking a mean XL bupropion HCl dose of 300 mg/day (range 150‒450 mg/day) for a mean duration of 88.8 weeks (range 4‒480 weeks). After 2 weeks on a mean XL bupropion HBr dose of 348 mg/day (range 174‒522 mg/day), these patients demonstrated a decrease in PHQ-9 scores from a mean of 15.3+5.3 on XL bupropion HCl to a mean of 6.4+5.0 on XL bupropion HBr (t=−8.63, p<0.00001). The most commonly encountered side effects with generic XL bupropion HCl were insomnia (21 patients), anxiety (19 patients), and gastrointestinal upset (2 patients), which resolved on XL bupropion HBr except for some residual insomnia (3 patients). 96.7% of patients (29 of 30) chose to continue on XL bupropion HBr rather than change back to generic XL bupropion HCl.

Conclusion: Adult patients suffering from Treatment-Resistant Depression experience rapid and significant improvement in mood with greater tolerability when switching from generic XL bupropion HCl to an equivalent dose of XL bupropion HBr.