WELL-ESTABLISHED TOLERABILITY
Adjunctive MDD
Weight and Metabolics
Weight change from baseline to endpoint in 6-week MDD studies1
| Mean change at endpoint | Proportion of patients with weight increase ≥7% | |
| Placebo + ADT (n=503) | +0.4 lb | 1% |
| VRAYLAR 1.5 mg/day + ADT (n=502) |
+1.5 lb | 2% |
| VRAYLAR 3 mg/day + ADT (n=503) |
+1.5 lb | 2% |
Metabolics and prolactin shifts from baseline to endpoint in 6-week MDD studies1,2
| Total cholesterol | Proportion of patients with metabolic shifts was similar to placebo† |
| Fasting triglycerides | |
| Fasting glucose | 97% of patients did not have a clinically meaningful increase in blood glucose‡ |
| Prolactin (ng/mL)§ | No meaningful increase in mean levels |
*In the 8-week MDD study, 2.5% of people taking VRAYLAR + ADT had a weight increase of ≥7% vs 2% of those taking placebo. The mean weight changes reported in this study were VRAYLAR 1-2 mg/day + ADT (n=273) = +1.98 lb; VRAYLAR 2-4.5 mg/day + ADT (n=273) = +1.98 lb; placebo + ADT (n=266) = 0 lb.1
†In the 6- and 8-week MDD studies, proportion of patients with metabolic shifts was similar to placebo. Shift defined as: total cholesterol: normal/borderline (<240 mg/dL) to high (≥240 mg/dL); fasting triglycerides: normal/borderline (<200 mg/dL) to high (≥200 mg/dL).1
‡In the 6-week studies, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL): VRAYLAR 1.5 mg/day + ADT=2%; VRAYLAR 3 mg/day + ADT=3.2%; placebo-treated=1.3%. The proportion of patients with shifts in fasting glucose from normal to borderline (≥100 and <126 mg/dL) or from borderline to high was similar in patients treated with VRAYLAR and placebo. In the 8-week study, the shifts in fasting glucose were similar among the VRAYLAR and placebo + ADT groups.1
§In two 6-week MDD studies, mean change from baseline in prolactin levels was 4.1 ng/mL and 3.8 ng/mL in the 1.5 mg/day + ADT group (baseline mean: 9.4 - 9.7) and 2.6 ng/mL and 2.9 ng/mL in the 3 mg/day group + ADT (baseline mean: 11.3 - 11.6) vs 1.2 ng/mL and 0.92 ng/mL in the placebo + ADT group (baseline mean: 9.7 - 10.5). In the 8-week MDD study, the mean change from baseline was 3.8 ng/mL in the 1-2 mg/day + ADT group (baseline mean: 8.8) and 4.1 ng/mL in the 2-4.5 mg/day + ADT group (baseline mean 9.4) vs 0.7 ng/mL in the placebo group (baseline mean: 9.4).2
Observed adverse reactions
Most common adverse reactions in two 6-week MDD studies
(≥5% and at least twice that of placebo)
| Placebo + ADT (n=503) |
VRAYLAR 1.5 mg/day + ADT (n=502) |
VRAYLAR 3 mg/day + ADT (n=503) |
|
| Insomnia|| | 5% | 9% | 10% |
| Nausea | 3% | 7% | 6% |
| Akathisia¶ | 2% | 7% | 10% |
||Insomnia terms: initial insomnia, insomnia, middle insomnia, poor sleep quality, sleep disorder, terminal insomnia.
¶Akathisia terms: akathisia, psychomotor hyperactivity, feeling jittery, nervousness, tension.
Most common adverse events in two trials that followed recommended titration
Discontinuation rates due to akathisia were 1.4% VRAYLAR + ADT and 0.4% Placebo + ADT2
Most common sexual adverse reactions in 6-week MDD studies2#
| Placebo + ADT (n=503) |
VRAYLAR 1.5 mg/day + ADT (n=502) |
VRAYLAR 3 mg/day + ADT (n=503) |
|
| Abnormal orgasm | 0% | 0% | 0.2% |
| Decreased libido | 0% | 0.2% | 0% |
| Erectile dysfunction | 0% | 0.2% | 0% |
| Ejaculation failure | 0% | 0.2% | 0% |
| Ejaculation disorder | 0% | 0% | 0% |
#These are self-reported adverse effects. If an adverse effect was not reported during a study, a value of 0 was used.