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OKEDI (rispéridone) - Schizophrénie

Opinions on drugs - Posted on Dec 12 2022

Reason for request

First assessment

Key points

Approval of reimbursement for the treatment of schizophrenia in adults whose tolerance and efficacy have been established with oral risperidone.

Therapeutic improvement?

No therapeutic improvement with respect to the conventional proprietary medicinal product RISPERDAL 4 mg (risperidone) film-coated tablet.

Role in therapeutic strategy?

Antipsychotics are the conventional pharmacological treatment for schizophrenia. They are used for acute phase treatment and as maintenance treatment to prevent relapses.

The choice of antipsychotic accounts for the response to treatments previously received, the safety profile of the antipsychotics and the patient’s individual susceptibility to adverse effects. Second-generation antipsychotics are recommended as a first-line approach as their safety is superior to that of first-generation antipsychotics. Antipsychotic monotherapy must be preferred.

A multidimensional approach is required for schizophrenia patients. Drug treatments must be associated with individual or group psychotherapy, institutional or family care and social interventions.

Prescribing a long-acting injectable form may be envisaged where the patient expresses a preference for this type of treatment and/or where compliance problems are observed in patients sufficiently stabilised by oral treatment during the initial treatment phase.

Role of OKEDI (risperidone) in the therapeutic strategy:

The proprietary medicinal products OKEDI (risperidone LP) powder and solvent for sustained-release injectable suspension provide a therapeutic alternative for the treatment of schizophrenia in adults whose tolerance and efficacy have been established with oral risperidone.


Clinical Benefit
Substantial

The Committee deems that the actual clinical benefit of OKEDI (risperidone) is significant in the indication and at the dosages of the marketing authorisation.

Clinical Added Value
no clinical added value

Considering:

  • the efficacy data solely based on a study conducted versus placebo for the treatment of acute schizophrenia relapse, moreover with a number of limitations raised (selected study population, different risperidone titration dosage for treatment-naive patients from that validated by the SPC, high attrition rates, etc.),
  • the lack of efficacy data versus active comparator making it possible to place the medicinal product in the therapeutic strategy, in a context where the therapeutic alternatives in sustained-release form which could be administered to patients whose tolerance and efficacy were established with oral risperidone (e., bimonthly injection of risperidone LP or paliperidone LP) demonstrating their non-inferiority versus active comparator,

but also considering

  • the bioequivalence established with the conventional proprietary medicinal product RISPERDAL 4 mg (risperidone) film-coated tablet,
  • the known safety profile of risperidone,
  • the benefit of having dosage forms enabling a different administration schedule,

the Committee deems that OKEDI (risperidone) provides no clinical added value (CAV V) in relation to the conventional proprietary medicinal product RISPERDAL 4 mg (risperidone) film-coated tablet.

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