For SCHIZOPHRENIA in adultsWell-established safety
and tolerability profile¹

0.5% of patients on CAPLYTA discontinued due to TEAEs in the pooled short-term trials²

Most common TEAEs in 4- to 6-week clinical trials^1,3,4*
	CAPLYTA (N=406)	Placebo (N=412)
Somnolence/ sedation	24%	10%
Dry mouth	6%	2%
	Dosed in morning

Somnolence with CAPLYTA was predominantly mild.³

The total discontinuation rate was 22.4% for patients on CAPLYTA 42 mg in 4- to 6-week clinical trials.²

All other adverse events occurred in <5% of patients or not more than twice the rate observed with placebo.¹

*TEAEs occurring in ≥2% of patients and at more than twice the rate of placebo in pooled short-term clinical trials.¹

TEAE=treatment-emergent adverse event.

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

Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for fall risk when initiating treatment and periodically during long-term treatment.

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

Relapse Trial Data

TEAEs were mild or moderate in severity for most patients⁴

Swipe table for more

TEAEs occurring in ≥5% of patients and at more than twice the rate of placebo in the double-blind phase⁴
	Open-label	Double-blind
	CAPLYTA (N=592)	CAPLYTA (n=110)	Placebo (n=114)
Headache	13.2%	8.2%	3.5%

TEAEs occurring in ≥5% of patients and at more than twice the rate of placebo in the double-blind phase⁴
	Open-label	Double-blind
	CAPLYTA (N=592)	CAPLYTA (n=110)	Placebo (n=114)
Headache	13.2%	8.2%	3.5%

Discontinuation due to AEs in the double-blind treatment period was similar to placebo at 1.8% (CAPLYTA, n=2; placebo, n=2).⁴

All other TEAEs in the double-blind treatment period occurred in <5% of patients or not more than twice the rate observed with placebo.⁴

One death was reported in the open-label treatment period. The cause of death was suicide, unrelated to study drug.⁴

SAEs occurred in 3.9% of patients during the open-label treatment period. SAEs occurred in 0.9% of patients in the CAPLYTA group and 6.1% of patients in the placebo group during the double-blind treatment period.⁴

AE=adverse event; SAE=serious adverse event; TEAE=treatment-emergent adverse event.

Relapse study design^1,4

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).⁴

^‡PANSS items P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness), P7 (hostility), G8 (uncooperativeness), and G14 (poor impulse control).⁴

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

See weight, metabolic effects, and prolactin

For SCHIZOPHRENIA in adultsWell-established safety and tolerability profile1

0.5% of patients on CAPLYTA discontinued due to TEAEs in the pooled short-term trials2

Somnolence with CAPLYTA was predominantly mild.3

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

TEAEs were mild or moderate in severity for most patients4

View study design

For SCHIZOPHRENIA in adultsWell-established safety
and tolerability profile¹

0.5% of patients on CAPLYTA discontinued due to TEAEs in the pooled short-term trials²

Somnolence with CAPLYTA was predominantly mild.³

TEAEs were mild or moderate in severity for most patients⁴