CHMP Backs Generic Paliperidone for Schizophrenia

Megan Brooks

May 02, 2020

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the antipsychotic Paliperidone Janssen-Cilag International (Janssen-Cilag International N.V.) for the treatment of schizophrenia.

This was an informed consent application, which makes use of data from the dossier of a previously authorized medicine. The reference product for Paliperidone Janssen-Cilag International is Xeplion.

Paliperidone Janssen-Cilag International will be available as prolonged-release suspension for injection in doses of 25, 50, 75, 100, or 150 mg.

The drug is indicated for maintenance treatment of schizophrenia in adults stabilized with paliperidone or risperidone.

"In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Paliperidone Janssen-Cilag International may be used without prior stabilization with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed," the EMA said in its summary opinion.

With long-term use, Paliperidone Janssen-Cilag International can reduce symptoms of schizophrenia (measured on a standard scale) and prevent new symptoms of schizophrenia, the agency said.

The most common side effects are insomnia, headache, anxiety, upper respiratory tract infection, injection-site reactions, parkinsonism, increased weight, akathisia, agitation, sedation/somnolence, nausea, constipation, dizziness, musculoskeletal pain, tachycardia, tremor, abdominal pain, vomiting, diarrhea, fatigue, and dystonia.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be made available in all official European Union languages following marketing authorization from the European Commission.

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