EFFICACY AND SAFETY OF WELLBUTRIN XL® COMPARED WITH OTHER ANTIDEPRESSANTS SUMMARY
Wellbutrin XL® (bupropion HCl extended-release tablets) is a once-daily formulation of bupropion indicated for the treatment of major depressive disorder (MDD) in adults aged 18 and older. Wellbutrin XL and Lexapro® (escitalopram oxalate, Forest Labs) have been compared with respect to antidepressant efficacy, effects on sexual functioning, and safety in 2 randomized, double-blind, placebo-controlled trials. Wellbutrin SR® (bupropion HCl) Sustained-Release Tablets and Zoloft® (sertraline hydrochloride, Pfizer) have been proven comparably effective in treating depression and accompanying symptoms of anxiety in 3 double-blind, randomized, multicenter studies. Wellbutrin SR and Prozac® (fluoxetine HCl, Eli Lilly and Company) have been compared with respect to antidepressant efficacy, effects on sexual functioning, and safety in 2 randomized, doubleblind, placebo-controlled clinical trials. A randomized, double-blind, controlled, clinical trial comparing Wellbutrin® (bupropion HCl) Tablets and fluoxetine found both to be similarly efficacious for the treatment of depression and accompanying symptoms of anxiety. Treatment-emergent adverse events were also similar. Wellbutrin SR and Paxil® (paroxetine HCl, GlaxoSmithKline) were shown to be comparably effective in treating depression and accompanying symptoms of anxiety in elderly depressed patients in a double-blind, randomized, multicenter study. Wellbutrin has also been compared to various tricyclic antidepressants (TCAs) in double-blinded studies.
Some information contained in this response may be outside the approved Prescribing Information for Wellbutrin XL. This response is not intended to offer recommendations for administering Wellbutrin XL in a manner inconsistent with its approved labeling. In order for GlaxoSmithKline to monitor the safety of Wellbutrin XL, we encourage healthcare professionals to report adverse events or suspected overdoses to the company at 888-825-5249. Please consult the Prescribing Information for Wellbutrin XL. BACKGROUND Studies have demonstrated similar bioavailability of the immediate-release and the extended-release formulations of bupropion under steady-state conditions (1).The bioavailability (both peak plasma concentration and extent of absorption) of Wellbutrin XL 300 mg once daily was similar to that of 100 mg 3 times daily of Wellbutrin for parent drug and metabolites. Similar studies have also demonstrated the bioequivalence of Wellbutrin XL and Wellbutrin SR. Based on bioequivalence, Wellbutrin XL offers similar efficacy and tolerability as other formulations of bupropion.
Table: Comparative Clinical Trials with Bupropion for the Treatment of Major Depressive Disorder Duration
8-wk treatment phase (2)
• Placebocontrolled • Double-blind • Randomized • N=410
Inclusion/ Exclusion Criteria
Inclusion Criteria • Males & females (≥18yrs) • Baseline HAMD-17 ≥19 • Current major depressive episode of 3-24 mns duration • Normal orgasmic function & willing to discuss sexual activity Exclusion Criteria • Arousal or orgasm dysfunction at screening or randomization • Hx of no response to 2 or more treatments for any depressive episode within 2 yrs • Prior treatment with bupropion within 3 mns • Hx of psychoactive drug including SSRIs within 2 wks (4 wks for fluoxetine) • Hx of MAOI use • Predisposition to seizure • Hx or current diagnosis of anorexia nervosa or bulimia • Hx unstable medical disorder • Actively suicidal • Pregnant or lactating Inclusion Criteria • Same as previous Exclusion Criteria • Sane as previous
Efficacy (N=388) • ∆ in HAMD-17 • HAD • CGI-I Sexual Functioning • Orgasm dysfunction • CSFQ • Sexual desire • Sexual arousal • Patient satisfaction Safety (N=410) • Weight • Vital Signs • AE Reports