CAPLYTA demonstrated statistically superior improvement vs placebo in 2 clinical trials1

For schizophrenia in adults

Significant improvement in PANSS total score over 4 weeks in Study 11*

Change in baseline in PANSS total score1,2

This graph depicts the change in total PANSS score over 4 weeks for patients receiving risperidone 4 mg, CAPLYTA 42 mg, or placebo.This graph depicts the change in total PANSS score over 4 weeks for patients receiving risperidone 4 mg, CAPLYTA 42 mg, or placebo.

This study was not designed to allow for efficacy comparison of CAPLYTA and risperidone. Risperidone was included for assay sensitivity.1,3

Baseline PANSS Total Scores: CAPLYTA 42 mg: 88.1; risperidone 4 mg: 86.1; placebo: 86.3.1,2

LSM=least squares mean; PANSS=Positive and Negative Syndrome Scale.

*The PANSS is a 30-item scale used to measure symptoms of schizophrenia. Each item is rated by a clinician on a 7-point scale. A score of 1 indicates the absence of symptoms, and a score of 7 indicates extremely severe symptoms. The PANSS total score may range from 30 to 210, with higher scores reflecting greater overall symptom severity.1

CAPLYTA separated from placebo as early as week 1 in Study 21,3,4

Change from baseline in PANSS total score over 4 weeks1,3,4

This graph depicts the change from baseline in PANSS total score over 28 days for patients receiving CAPLYTA 42 mg or placebo.This graph depicts the change from baseline in PANSS total score over 28 days for patients receiving CAPLYTA 42 mg or placebo.

Limitation: The weekly time points prior to 4 weeks were not powered for statistical comparison and are descriptive only.

Baseline PANSS Total Scores: CAPLYTA 42 mg: 90.0; placebo: 89.01

‡P=nominal.3

§P<0.05 vs placebo.3

CAPLYTA demonstrated significant improvement in clinical global impression-severity (CGI-S) scores4‖

CGI-S was a secondary endpoint3

Patients on CAPLYTA 42 mg saw a 0.8 improvement in CGI-S score vs 0.5 on placebo (P<0.05). Baseline CGI-S scores (mean) were 4.8 for CAPLYTA 42 mg and placebo.3

‖The CGI-S asks the clinician how mentally ill the patient is, which is rated on the following 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.5

See CAPLYTA secondary endpoint data in schizophrenia
PANSS Subscales

Frequently Asked Questions

Was risperidone an active control or active comparator in Study 1?

In Study 1, risperidone was an active comparator and included for assay sensitivity.2 The study was not designed to allow for efficacy comparison of CAPLYTA and risperidone.1

Can CAPLYTA be used for first break psychosis in schizophrenia, including first-episode psychosis?

CAPLYTA is indicated for the treatment of schizophrenia in adults. CAPLYTA may be used at any point across the spectrum and severity of disease.1

CAPLYTA is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.

Important Safety Information

Boxed Warnings:

  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
  • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

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

  • Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
  • Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and provide intensive symptomatic treatment and monitoring.
  • Tardive Dyskinesia (TD), a syndrome of potentially irreversible, dyskinetic, and involuntary movements which may increase as the duration of treatment and total cumulative dose increases. The syndrome can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. Given these considerations, CAPLYTA should be prescribed in a manner most likely to reduce the risk of TD. Discontinue CAPLYTA if clinically appropriate.
  • 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.
  • Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors.
  • Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
  • 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 risk when using CAPLYTA.
  • Seizures. Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
  • Potential for Cognitive and Motor Impairment. Advise patients to use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
  • Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
  • Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration.

Drug Interactions: Avoid concomitant use with CYP3A4 inducers. Reduce dose for concomitant use with strong CYP3A4 inhibitors (10.5 mg) or moderate CYP3A4 inhibitors (21 mg).

Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Reduce dose for patients with moderate or severe hepatic impairment (21 mg).

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs placebo were:

  • Schizophrenia: somnolence/sedation (24% vs 10%) and dry mouth (6% vs 2%).
  • Bipolar Depression (Monotherapy, Adjunctive therapy): somnolence/sedation (13% vs 3%, 13% vs 3%), dizziness (8% vs 4%, 11% vs 2%), nausea (8% vs 3%, 9% vs 4%), and dry mouth (5% vs 1%, 5% vs 1%).

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

Indications

CAPLYTA is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.

Please see full Prescribing Information, including Boxed Warnings.

References: 1. CAPLYTA prescribing information. 2. Lieberman JA, Davis RE, Correll CU, et al. CAPLYTA for the treatment of schizophrenia: a 4-week randomized, double-blind, controlled trial. Biol Psychiatry. 2016;79(12):952-961. Accessed May 1, 2024. 3. Data on File (REF-00332, REF-00360). 4. Correll CU, Davis RE, Weingart M, et al. Efficacy and safety of lumateperone for treatment of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2020;77(4):349-358. Accessed May 1, 2024. 5. Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007;4(7):28-37. Accessed May 1, 2024.

Boxed Warnings:

  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.