In patients with MDD experiencing partial response, REXULTI taken with antidepressants amplified antidepressant symptom response
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MDD study design summary
REXULTI was studied in two 6-week, double-blind, placebo-controlled, fixed-dose pivotal trials of adult patients meeting DSM-IV-TR criteria for MDD. After a screening phase of 1-4 weeks, patients who met inclusion criteria were treated with an SSRI or SNRI for 8 weeks. Patients who met criteria for persistent partial responsea to an 8-week prospective treatment with an antidepressant were randomized to receive adjunctive REXULTI. Approximately 49% of patients in the 2 trials had symptoms of anxiety at randomization.1-3,b
Primary endpoint was the mean change from baseline to Week 6 in the MÅDRS total score in the randomization phase1,2
aPersistent partial response criteria (prospective phase) included: <50% reduction in HAM-D17 Total Score and ≥14 HAM-D17 score at Week 8; <50% reduction in MÅDRS Total Score and Clinical Global Impression-Improvement Score of ≥3 at each scheduled visit.1,2
bPresence of anxiety symptoms was defined by a HAM-D anxiety/somatization factor of ≥7.4
DSM-IV-TR, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision); HAM-D17, 17-item Hamilton Depression Rating Scale; MÅDRS, Montgomery-Åsberg Depression Rating Scale.
REXULTI added to an antidepressant achieved a 62% greater reduction in Montgomery-Åsberg Depression Rating Scale (MÅDRS) total score vs antidepressants alone (+ placebo)
an=379 patients with confirmed partial response to ADT + single-blind placebo. Persistent partial response criteria (prospective phase) included: <50% reduction in HAM-D17 Total Score and ≥14 HAM-D17 score at Week 8; <50% reduction in MÅDRS Total Score and Clinical Global Impression-Improvement Score of ≥3 at each scheduled visit.1,2
*p<0.05, **p<0.01, <0.001 vs placebo. MÅDRS before prospective treatment (SD): 31.0 (4.7).5 MÅDRS after prospective treatment (SD): 27.1 (5.7).5 MÅDRS at randomization (SD): ADT + placebo (n=178), 27.3 (5.6); ADT + REXULTI 2 mg/day (n=175), 26.9 (5.7).
MEAN CHANGE FROM BASELINE ACROSS TWO PIVOTAL TRIALS
At the 2-mg/day recommended dose, the mean change from baseline (SE) at 6 weeks (randomized phase) was -8.4 (0.6) for ADT + REXULTI vs -5.2 (0.6) for ADT + placebo (-3.2 [95% CI: -4.9, -1.5], p=0.0002).1,b At the 3-mg/day maximum dose, the mean change from baseline (SE) at 6 weeks (randomized phase) was -8.3 (0.5) for ADT + REXULTI vs -6.3 (0.5) for ADT + placebo (-2.0 [95% CI: -3.4, -0.5], p=0.0079).2 At the 3-mg dose, the MÅDRS baseline (SD) for ADT + REXULTI (n=213) and ADT + placebo (n=203) was 26.5 (5.3) and 26.5 (5.2), respectively.2
aDose statistically significantly superior to placebo.
ADT, antidepressant treatment; CI, confidence interval; SD, standard deviation; SE, standard error.
The efficacy and safety of REXULTI was also studied in patients randomized to receive 1 mg/day in Study 2 (n=211). Results for the ADT + REXULTI 1 mg group for the primary efficacy parameter were not statistically significant when compared with ADT + placebo; p=0.0737.2
Contraindication:
In patients with known hypersensitivity reaction to brexpiprazole or any of its components. Reactions have included: rash, facial swelling, urticaria and anaphylaxis.
- Titration—all patients randomized to REXULTI initiated treatment at 0.5 mg/day during Week 1. At Week 2, the REXULTI dose was increased to 1 mg/day and either maintained at 1 mg/day or increased to 2 mg/day or 3 mg/day, based on treatment assignment, from Week 3 onward
- Primary endpoint—change from baseline to Week 6 in MÅDRS in the randomization phase1,2
aPersistent inadequate response criteria (prospective phase) included: <50% reduction in HAM-D17 Total Score and ≥14 HAM-D17 score at Week 8; <50% reduction in MÅDRS Total Score and Clinical Global Impression-Improvement Score of ≥3 at each scheduled visit.1,2
bThe efficacy and safety of REXULTI 1 mg/day were also studied in Study 2 (n=211).
cn values represent efficacy population per final protocol1,2.
dPresence of anxiety symptoms was defined by HAM-D anxiety/somatization factor of ≥74
ATRQ: Antidepressant Treat Response Questionnaire; CR: controlled release; DR: delayed release; HAM-D17: 17-item Hamilton Depression Rating Scale; SNRI: serotonin and norepinephrine reuptake inhibitor; SSRI: selective serotonin reuptake inhibitor; XR: extended release.
Continue exploring REXULTI
Safety Profile
See safety profile demonstrated across 2 clinical trials.
Dosing Information
Learn about once-daily treatment with a target dose of 2 mg.
