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%

In the 8-week study, mean change <2 lb in patients treated with VRAYLAR + antidepressant*

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

In two 6-week MDD studies, 4% of patients who received VRAYLAR discontinued treatment compared with 2% of placebo-treated patients when following recommended titration schedule1

There were no adverse reactions leading to discontinuation that occurred at a rate of ≥2% in VRAYLAR patients and at least twice the rate of placebo

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.