Intra-Cellular Therapies Showcases Data at ASCP Annual Meeting

Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company specializing in treatments for central nervous system (CNS) disorders, has recently showcased significant data at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami, held from May 28 to 31, 2024. The presentation highlighted the efficacy, safety, and tolerability of CAPLYTA® (lumateperone) in treating bipolar I and II disorder and major depressive disorder (MDD) with mixed features during major depressive episodes.

Several posters were presented at the ASCP meeting:

- Poster W49 discussed the use of lumateperone for patients with MDD and bipolar disorder experiencing anxious distress and mixed features.
- Poster T40 focused on lumateperone’s efficacy across various symptoms in MDD and bipolar depression with mixed features.
- Poster T41 examined lumateperone’s effectiveness in treating major depressive episodes with mixed features in MDD, bipolar I, or bipolar II disorder.

CAPLYTA® is approved for treating schizophrenia in adults and depressive episodes associated with bipolar I or II disorder, either as monotherapy or combined with lithium or valproate. However, several safety concerns and contraindications are associated with its use.

Important Safety Information

Boxed Warnings:

1. Increased Mortality in Elderly Patients with Dementia-Related Psychosis:** Elderly patients treated with antipsychotic drugs for dementia-related psychosis are at greater risk of death. CAPLYTA is not approved for such treatments.
2. Suicidal Thoughts and Behaviors in Pediatric and Young Adults:** Antidepressants may elevate the risk of suicidal thoughts and actions in young individuals. Monitoring for clinical worsening and emergence of suicidal tendencies is crucial.

Contraindications:
CAPLYTA should not be used by patients with known hypersensitivity to lumateperone or its components, as reactions can include pruritus, rash, and urticaria.

Warnings & Precautions:

- Cerebrovascular Adverse Reactions: Elderly patients with dementia-related psychosis are at risk of strokes and transient ischemic attacks.
- Neuroleptic Malignant Syndrome (NMS): This potentially fatal condition includes symptoms like high fever, muscle stiffness, confusion, and altered heart rate and blood pressure.
- Tardive Dyskinesia: This syndrome involves involuntary movements, which may persist or even appear after discontinuing CAPLYTA.
- Metabolic Changes: These can include hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain.
- Leukopenia, Neutropenia, and Agranulocytosis: Monitoring white blood cell counts is essential in patients with a history of low WBC.

Other Concerns:
- Orthostatic Hypotension: Rapid changes in posture may cause dizziness or fainting.
- Fall Risks: CAPLYTA may induce sleepiness or dizziness, heightening the risk of falls.
- Seizures: Caution should be exercised in patients with a history of seizures.
- Cognitive and Motor Impairment: Until patients understand how CAPLYTA affects them, they should exercise caution when operating machinery.
- Body Temperature Dysregulation: Caution is advised in patients exposed to conditions that may elevate core body temperature.
- Dysphagia: Care is required for patients at risk of aspiration.

Drug Interactions:
CAPLYTA should not be combined with CYP3A4 inducers. Dose adjustments are recommended when used with strong or moderate CYP3A4 inhibitors.

Special Populations:
- Newborns: Infants exposed to antipsychotics during pregnancy may experience withdrawal symptoms.
- Hepatic Impairment: Dose reductions are advised for patients with moderate or severe liver dysfunction.

About Intra-Cellular Therapies

Intra-Cellular Therapies, founded on Nobel prize-winning research, focuses on developing treatments for complex psychiatric and neurologic conditions by understanding cellular mechanisms. CAPLYTA, at 42 mg, is an atypical antipsychotic approved for schizophrenia and bipolar depression in adults.

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