For SCHIZOPHRENIA in adultsWeight change, metabolic effects, and prolactin

Pooled safety data from 4- to 6-week trials¹
BODY WEIGHT (mean change from baseline)	CAPLYTA (N=406)	Placebo (N=412)
Average weight change (lbs)	+3.5	+2.9
Metabolic profile (mean change from baseline, mg/dL)
Glucose	+0.7	+2.1
Insulin (μIU/mL)	+2.4	+0.9
Total cholesterol	-3.0	-1.6
LDL cholesterol	+1.2	+1.0
HDL cholesterol	-3.3	-4.2
Triglycerides	-1.7	+4.6
Prolactin (ng/mL)	-1.3	-0.2

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.

Please see additional Important Safety Information, including Boxed WARNINGS, below.

Changes in weight and metabolic effects were similar to placebo¹

CAPLYTA mean change from baseline was similar to placebo in terms of glucose, total cholesterol, and triglycerides¹

Relapse Trial Data

Changes in body weight and metabolic effects were similar to placebo¹

Body morphology, prolactin, and cardiometabolic parameters in the double-blind study^1*
BODY WEIGHT (mean change from baseline)	CAPLYTA (n=110)	Placebo (n=114)
Weight (lb)	0.4	-0.2
BMI (kg/m²)	0.1	0.0
Waist circumference (in)	0.2	-0.4
Metabolic profile (mean change from baseline, mg/dL)
Prolactin (ng/mL)	-3.3	-2.9
Total cholesterol	-6.1	-0.8
HDL cholesterol	2.0	4.9
LDL cholesterol	-4.8	-2.9
Triglycerides	-11.0	-3.3
Glucose	2.0	-2.3
Insulin (μIU/mL)	3.2	2.6

Potentially clinically significant weight increase and decrease (≥7% change from open-label treatment baseline) occurred at similar rates in the CAPLYTA and placebo groups at the end of double-blind treatment.^1†

*Mean change from baseline of open-label treatment to end of double-blind treatment. Baseline was defined as the last assessment before the first dose of open-label study drug.¹

^†Increases: 11.8% (CAPLYTA) vs 9.7% (placebo). Decreases: 13.6% (CAPLYTA) vs 9.7% (placebo).¹

BMI=body-mass index; HDL=high-density lipoprotein; LDL=low-density lipoprotein.

Relapse study design^1,2

Open-label treatment period: Adults (N=592) aged 18–60 years with schizophrenia experiencing a current psychotic episode received open-label CAPLYTA 42 mg once daily for 18 weeks. The mean treatment duration was 74.8 days during the open-label CAPLYTA treatment period.

Double-blind treatment period: Patients (n=228) who achieved stability by the end of the 6-week run-in period and were still stable at Week 18 were randomized 1:1 to double-blind treatment with CAPLYTA 42 mg or placebo for 26 weeks or until relapse. During the double-blind treatment period, mean treatment duration was 144.5 days for the CAPLYTA group and 111.9 days for the placebo group.

Primary endpoint: Time to relapse during double-blind treatment.

18-Week Open-label CAPLYTA 42 mg

6-Week Run-In

12-Week Stabilization

Week 18

Stable
Patients 1:1

To Week 44
or Relapse

Enrolled:

18-60 years (incl)
DSM-5 schizophrenia ≥1 year
PANSS total score 70-120 (incl) at visit 1 and visit 2
Score ≥4 on ≥2 PANSS items^‡ at visit 1 and visit 2

At the end of the run-in period, stable patients continued treatment in stabilization period and others were discontinued

Stable defined as:

PANSS total score ≤60
≥20% PANSS total score decrease from baseline
CGI-S score ≤4
Score ≤4 on 7 PANSS items^§
No suicidal or homicidal ideation
No tolerability issues

Relapse defined as ≥1 of:

Psychiatric hospitalization or increased psychiatric care
PANSS total score increase by ≥30% (if score ≥50 at randomization) or ≥10 points (if <50 at randomization)
CGI-S score increase by ≥2 points
Aggressive/violent behavior or self-injury
Suicidal or homicidal ideation
Score >4 on ≥1 of 7 PANSS items^§

^‡PANSS items P1 (delusions), P3 (hallucinatory behavior), P2 (conceptual disorganization), and P6 (suspiciousness/persecution).¹

^§PANSS items P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness), P7 (hostility), G8 (uncooperativeness) and G14 (poor impulse control).¹

CGI-S=Clinical Global Impression-Severity of Illness scale; DSM=Diagnostic and Statistical Manual of Mental Disorders; PANSS=Positive and Negative Syndrome Scale.

Open-label safety switch study

Patients switching to CAPLYTA for 6 weeks observed changes in metabolic and prolactin parameters^1,3

Swipe chart for more

Changes observed in patients
switching from another antipsychotic
to CAPLYTA for 6 weeks

Limitation: This open-label trial was designed primarily to assess safety and tolerability. Efficacy outcomes are exploratory and should be interpreted with caution, as the study was not powered or controlled to assess treatment efficacy.

The most frequently occurring TEAEs (≥5% of patients) were somnolence, headache, and dry mouth.³

The most common antipsychotics in the pre-/post-treatment period were risperidone, quetiapine, aripiprazole, and olanzapine.³

TEAE=treatment-emergent adverse event.

Open-label safety switch study (6-week)

Designed to assess outcomes in patients that switched to CAPLYTA^1,3

Study design

Open-label trial of adult patients with stable schizophrenia
Switched from a previous antipsychotic to CAPLYTA 42 mg for 6 weeks
Followed by a 2-week switch to another approved antipsychotic
Stable schizophrenia was defined as:
- – No hospitalization for psychiatric illness within 3 months of Day 1
- – A CGI-S score ≤4 at screening and baseline
- – A score ≤4 on each of 4 core positive subscale items of the PANSS at baseline

Primary endpoint: Safety

Most TEAEs were mild (53.3%) to moderate (43.1%) in severity in the CAPLYTA switch group
No new safety concerns were identified with CAPLYTA
TEAEs led to discontinuation of 23 patients (7.6%); 14 patients (<5%) discontinued due to drug-related TEAEs

Most frequently occurring TEAEs (≥5% of patients)
	CAPLYTA (N=301)
Somnolence/sedation	6.6%
Headache	5.3%
Dry mouth	5.3%

EPS-related TEAEs (% of patients)^‖
	CAPLYTA (N=301)
Any EPS-related event (including akathisia)	3.7%
Akathisia	0.3%

Limitation: This open-label safety trial was designed primarily to assess long-term safety and tolerability. Efficacy outcomes are exploratory and should be interpreted with caution, as the study was not powered or controlled to assess treatment efficacy.

^‖EPS (extrapyramidal symptoms) include muscle spasms, extrapyramidal disorder, musculoskeletal stiffness, tremor, akathisia, muscle twitching, blepharospasm, dyskinesia, hypokinesia, movement disorder, restlessness, and tardive dyskinesia.

CGI-S=Clinical Global Impression-Severity of Illness scale; EPS=extrapyramidal symptoms; PANSS=Positive and Negative Syndrome Scale; TEAE=treatment-emergent adverse event.

See sexual side effects and EPS

For SCHIZOPHRENIA in adultsWeight change, metabolic effects, and prolactin

Changes in body weight and metabolic effects were similar to placebo1

View study design

Changes observed in patients switching from another antipsychotic to CAPLYTA for 6 weeks

View study design

Changes in body weight and metabolic effects were similar to placebo¹

Changes observed in patients
switching from another antipsychotic
to CAPLYTA for 6 weeks