Asenapine Treatment in Pediatric Patients with Bipolar I Disorder or Schizophrenia: A Review

Research output: Contribution to journalArticle

Abstract

Asenapine, administered as a twice-daily (BID) sublingual tablet, is approved in the US as monotherapy for the acute treatment of manic and mixed episodes of bipolar I disorder in children and adolescents aged 10–17 years based on the positive results of one 3-week, double-blind, placebo-controlled study; the recommended dose is 2.5–10 mg BID. Although asenapine has been studied in pediatric patients with schizophrenia, it is not approved for this indication. Asenapine is not approved for pediatric use in bipolar I disorder or schizophrenia in other major markets. To inform clinicians treating psychiatric disorders in pediatric patients, we have summarized the neuropharmacology, pharmacokinetics, clinical trial experience, and clinical use of asenapine in pediatric patients. After rapid absorption through the oral mucosa, the pharmacokinetic profile of asenapine in pediatric patients is similar to that which is observed in adult patients, indicating that the recommended adult dosage does not need to be adjusted for pediatric use. Intake of food and water should be avoided for 10 min after administration. In clinical trials, asenapine was generally safe and well tolerated in pediatric patients with bipolar I disorder and schizophrenia. Serious adverse effects were generally related to worsening of the underlying psychiatric disorder. The most common treatment-emergent adverse events (TEAEs) in both indications were sedation and somnolence. Like some other second-generation antipsychotic agents, weight gain and changes in some metabolic parameters were noted; oral effects (e.g., oral hypoesthesia, dysgeusia, paresthesia) related to sublingual administration did not typically result in treatment discontinuation and were generally transient. Extrapyramidal symptom TEAEs occurred in ≥5% of asenapine-treated patients in the acute and long-term studies in bipolar I disorder and schizophrenia.

Original languageEnglish (US)
Pages (from-to)1-14
Number of pages14
JournalPediatric Drugs
DOIs
StateAccepted/In press - Nov 23 2017

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Bipolar Disorder
Schizophrenia
Pediatrics
Therapeutics
Psychiatry
Pharmacokinetics
Dysgeusia
Sublingual Administration
Neuropharmacology
Clinical Trials
Hypesthesia
Paresthesia
Mouth Mucosa
Asenapine
Antipsychotic Agents
Tablets
Drinking
Weight Gain
Eating
Placebos

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Pharmacology (medical)

Cite this

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title = "Asenapine Treatment in Pediatric Patients with Bipolar I Disorder or Schizophrenia: A Review",
abstract = "Asenapine, administered as a twice-daily (BID) sublingual tablet, is approved in the US as monotherapy for the acute treatment of manic and mixed episodes of bipolar I disorder in children and adolescents aged 10–17 years based on the positive results of one 3-week, double-blind, placebo-controlled study; the recommended dose is 2.5–10 mg BID. Although asenapine has been studied in pediatric patients with schizophrenia, it is not approved for this indication. Asenapine is not approved for pediatric use in bipolar I disorder or schizophrenia in other major markets. To inform clinicians treating psychiatric disorders in pediatric patients, we have summarized the neuropharmacology, pharmacokinetics, clinical trial experience, and clinical use of asenapine in pediatric patients. After rapid absorption through the oral mucosa, the pharmacokinetic profile of asenapine in pediatric patients is similar to that which is observed in adult patients, indicating that the recommended adult dosage does not need to be adjusted for pediatric use. Intake of food and water should be avoided for 10 min after administration. In clinical trials, asenapine was generally safe and well tolerated in pediatric patients with bipolar I disorder and schizophrenia. Serious adverse effects were generally related to worsening of the underlying psychiatric disorder. The most common treatment-emergent adverse events (TEAEs) in both indications were sedation and somnolence. Like some other second-generation antipsychotic agents, weight gain and changes in some metabolic parameters were noted; oral effects (e.g., oral hypoesthesia, dysgeusia, paresthesia) related to sublingual administration did not typically result in treatment discontinuation and were generally transient. Extrapyramidal symptom TEAEs occurred in ≥5{\%} of asenapine-treated patients in the acute and long-term studies in bipolar I disorder and schizophrenia.",
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