For SCHIZOPHRENIA in adultsEPS-related TEAEs and
sexual side effects

Pooled safety data from 4- to 6-week trials^1-3
INCIDENCE OF EPS AND AKATHISIA	CAPLYTA (N=406)	Placebo (N=412)
EPS^* (including akathisia)	6.7%	6.3%
Akathisia²	2.0%	2.9%
CHANGE IN MOVEMENT SCORES FROM BASELINE^1†
BARS	-0.1	0.0
AIMS	+0.1	0.0
SAS	+0.1	0.0
Incidence of SEXUAL SIDE EFFECTS³
Erectile dysfunction	0.0%	0.5%
Libido decreased	0.0%	0.0%
Erection increased	0.2%	0.0%
Spontaneous penile erection	0.0%	0.0%

*EPS (extrapyramidal symptoms) include akathisia, extrapyramidal disorder, muscle spasms, restlessness, musculoskeletal stiffness, dyskinesia, dystonia, muscle twitching, tardive dyskinesia, tremor, drooling, and involuntary muscle contractions.¹

^†BARS ranges from 0 to 14. AIMS for dyskinesia total score ranges from 0 to 28. SAS for EPS ranges from 0 to 40. Movement scores represent mean change from baseline.¹

AIMS=Abnormal Involuntary Movement Scale; BARS=Barnes Akathisia Rating Scale; SAS=Simpson-Angus Scale.

Relapse Trial Data

Rates of EPS-related TEAEs were similar to placebo in the double-blind phase³

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No notable changes from baseline in EPS as assessed by standard abnormal movement scales (AIMS, BARS, SAS).³

^‡According to the MedDRA query narrow criteria for EPS-related TEAEs.³

AIMS=Abnormal Involuntary Movement Scale; BARS=Barnes Akathisia Rating Scale; EPS=extrapyramidal symptom; MedDRA=Medical Dictionary for Regulatory Activities; SAS=Simpson-Angus Scale; TEAE=treatment-emergent adverse event.

Relapse study design^1,3

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).³

^‖PANSS items P1 (delusions), P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspiciousness), P7 (hostility), G8 (uncooperativeness), and G14 (poor impulse control).³

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

Explore the long-term data for
CAPLYTA

EPS-related TEAEs³
	Open-label	Double-blind
	CAPLYTA (N=592)	CAPLYTA (n=110)	Placebo (n=114)
EPS-related TEAEs^‡	2.7%	0.9%	0.9%
Akathisia	2.5%	0.9%	0.9%
Bradykinesia	0.2%	0.0%	0.0%
Parkinsonism	0.2%	0.0%	0.0%

EPS-related TEAEs³
	Open-label	Double-blind
	CAPLYTA (N=592)	CAPLYTA (n=110)	Placebo (n=114)
EPS-related TEAEs^‡	2.7%	0.9%	0.9%
Akathisia	2.5%	0.9%	0.9%
Bradykinesia	0.2%	0.0%	0.0%
Parkinsonism	0.2%	0.0%	0.0%

For SCHIZOPHRENIA in adultsEPS-related TEAEs and sexual side effects

Rates of EPS-related TEAEs were similar to placebo in the double-blind phase3

View study design

For SCHIZOPHRENIA in adultsEPS-related TEAEs and
sexual side effects

Rates of EPS-related TEAEs were similar to placebo in the double-blind phase³