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ATC codes: N05AX13
Indication
Schizophrenia or other primary psychotic disorders ICD11 code: 6A4Z
INN
Paliperidone
Medicine type
Chemical agent
List type
Core
Formulations
Parenteral > General injections > IM: 25 mg in pre-filled syringe (as palmitate) ; 50 mg in pre-filled syringe (as palmitate) ; 75 mg in pre-filled syringe (as palmitate) ; 100 mg in pre-filled syringe (as palmitate) ; 150 mg in pre-filled syringe (as palmitate)
EML status history
First added in 2021
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
Medicines within the same pharmacological class can be used
Patent information
Patents have expired in most jurisdictions
Expert Committee recommendation
The Expert Committee considered that long-acting injectable antipsychotic medicines are a valuable treatment option to increase adherence to treatment and reduce relapse in adults with schizophrenia and related psychotic disorders. The Committee also noted with concern the uncertainty of current and future availability of fluphenazine injection, which is the only long-acting injectable antipsychotic medicine included on the EML at the moment, and considered that the availability of alternative medicines would be important to meet the public health need for such treatments. The Committee noted that long-acting injectable antipsychotic medicines are an established treatment option for schizophrenia and are recommended in existing WHO (mhGAP) guidelines. In particular, the Committee acknowledged that long-acting injectable antipsychotic medicines are useful in low-resource settings, where many factors might impede regular monitoring and follow-up of patients. The Committee noted that the available data suggest benefits of long-acting injectable antipsychotic medicines versus oral antipsychotic medicines in preventing hospitalization or relapse, especially in populations with low treatment adherence. The effectiveness and overall safety of first-generation and second-generation antipsychotic medicines are similar. The availability of agents with different side-effect profiles may support the selection of one treatment over another given a patient’s clinical status and vulnerabilities. The Expert Committee therefore recommended the addition of paliperidone palmitate 1-month long-acting injection to the core list of the EML for maintenance treatment of schizophrenia in adults stabilized on oral therapy. The listing is recommended with a square box specifying risperidone long-acting injection as a therapeutic alternative. The Committee also noted and welcomed the planned comprehensive review by the WHO Department of Mental Health and Substance Use of the mental health sections of the EML and EMLc to achieve optimal alignment between the Model Lists and recommendations of the WHO mental health treatment guidelines.