For SCHIZOPHRENIA in adults84% of patients were relapse-free with CAPLYTA over 6 months¹*

CAPLYTA significantly delayed time to relapse vs placebo^1,2

relapse-free
over 6 months¹*

reduction in risk
of relapse^1†

Reconsider your schizophrenia treatment approach.
Prescribe CAPLYTA for your appropriate patients²

*In the ITT population, fewer relapses occurred with CAPLYTA (n=18, 16%) vs placebo (n=44, 39%); Clinical significance, NNT=5.¹

^†HR (95% CI): 0.37 (0.22–0.65); P=0.0002. P value for prespecified primary analysis using the log-rank test. Estimates of HR and 95% CI based on the Cox proportional hazards model with treatment group as the explanatory variable.¹

Secondary Endpoint: Double-blind treatment period

CAPLYTA significantly delayed time to all-cause discontinuation (including relapse) vs placebo^1‡

reduction in risk of
all-cause discontinuation^1§

Patients on CAPLYTA
were less likely to
discontinue treatment^1‡

31%
CAPLYTA (n=34)

53%
Placebo (n=60)

^‡Based on ITT population.¹

^§HR (95% CI): 0.49 (0.32–0.75); P =0.0007. P value based on log-rank test. Estimates of HR and 95% CI based on the Cox proportional hazards model with treatment group as the explanatory variable.¹

CI=confidence interval; HR=hazard ratio; ITT=intent-to-treat.

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.

See CAPLYTA subscale data in schizophrenia

For SCHIZOPHRENIA in adults84% of patients were relapse-free with CAPLYTA over 6 months1*

CAPLYTA significantly delayed time to relapse vs placebo1,2

CAPLYTA significantly delayed time to all-cause discontinuation (including relapse) vs placebo1‡

View study design

Relapse study design1,2

For SCHIZOPHRENIA in adults84% of patients were relapse-free with CAPLYTA over 6 months¹*

CAPLYTA significantly delayed time to relapse vs placebo^1,2

CAPLYTA significantly delayed time to all-cause discontinuation (including relapse) vs placebo^1‡

Relapse study design^1,2