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  5. Drug Trials Snapshots: CAPLYTA
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Drug Trials Snapshots: CAPLYTA

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the CAPLYTA Package Insert for complete information.

CAPLYTA (lumateperone)
Kah-PLY’-tah
Intra-Cellular Therapies, Inc.
Approval date: December 20, 2019


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

CAPLYTA is a drug used for the treatment of schizophrenia in adults.

Schizophrenia is a brain disorder with symptoms that include hearing voices, believing that other people are reading one’s mind or controlling their thoughts, and being suspicious or withdrawn.

How is this drug used?

CAPLYTA is a capsule that is taken once a day.

What are the benefits of this drug?

CAPLYTA improved symptoms of schizophrenia.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex:  CAPLYTA worked similarly in men and women.
  • Race: CAPLYTA worked similarly in Black or African American and White patients.
  • Age: CAPLYTA worked similarly in patients younger and older than 40 years of age. There were no patients older than 60 years; therefore, it is not known if there are any differences in how well CAPLYTA works in older patients.

 

What are the possible side effects?

CAPLYTA may cause serious side effects including:

  • Increased risk of death in the elderly with dementia-related psychosis (elderly who have lost touch with reality [psychosis] due to confusion and memory loss [dementia]).
  • Increased risk of stroke in elderly patients with dementia-related psychosis
  • Neuroleptic syndrome (life threatening condition that includes fever, stiff muscles and altered mental status)
  • Tardive dyskinesia (uncontrolled involuntary movements of the face, tongue, arms, legs, and other body parts)
  • Weight gain and high blood glucose and lipids
  • Low white blood cell counts
  • Decrease in blood pressure upon standing and loss of consciousness
  • Falls
  • Seizures
  • Impaired ability to operate machinery

The most common side effects of CAPLYTA are sleepiness and dry mouth.

 

Were there any differences in side effects among sex, race and age?

  • Sex:  The occurrence of side effects was similar in men and women.
  • Race:  The risk of overall side effects was similar in Black or African American and White patients.
  • Age: The occurrence of side effects was similar in patients younger and older than 40 years of age. There were no patients older than 60 years; therefore, it is not known if the side effects in older patients are similar to those in younger patients.

 

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the trials?

The FDA approved CAPLYTA based on evidence from three clinical trials (Trial 1/NCT01499563, Trial 2/NCT02282761 and Trial 3/NCT02469155) that enrolled 818 adult patients with schizophrenia. The trials were conducted at 33 sites in the United States.

Trials 1 and 2 provided data on the benefits and side effects of CAPLYTA, and Trial 3 provided data on side effects only.

The figure below summarizes the numbers of men and women who participated in the three clinical trials and received at least one dose of trial drug (safety population).

Figure 1. Demographics by Sex (safety population)

(Alt-Tag: Pie chart summarizing how many men and women were in the clinical trial. In total,  199 women (76%) and 619 men (24%) participated in the clinical trial.)

Clinical Trial Data

The figure below summarizes how many patients participated in the clinical trials by race.

Figure 2. Demographics by Race (safety population)

(Alt-Tag: Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 170 White (75%), 6 Asian (21%) and 612 Black or African American  (75%) and 23 Other (3%)).

*Includes Other, American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander
Clinical Trial Data

The figure below summarizes how many patients participated in the clinical trials by age.

Figure 3. Demographics by Age (safety population)

(Alt-Tag: Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total,  361 (44%) were 18-40 years, and 457 (56%) of patients were 40-60 years and older.)

Clinical Trial Data

How were the trials designed?

Three trials provided data for CAPLYTA’s approval. In each trial, hospitalized patients with schizophrenia were randomly assigned to receive either CAPLYTA or a comparison treatment (placebo or active comparator) once daily for 4 weeks (Trials 1 and 2) or 6 weeks (Trial 3). Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed.

Trials 1 and 2 provided data for the assessment of benefits and side effects through 4 weeks of therapy. Benefit was assessed by measuring the overall improvement in the symptoms of schizophrenia. 

Trial 3 provided data for the assessment of side effects only during 6 weeks of therapy.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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