TREVICTA (paliperidone), antipsychotic
PSYCHIATRY - New medicinal product
Opinions on drugs - Posted on Dec 12 2016
Reason for request
No clinical benefit demonstrated for a 3-monthly injection when compared with monthly injections of paliperidone in the maintenance treatment of schizophrenia.
- TREVICTA, a 3-monthly injection, has Marketing Authorisation in the maintenance treatment of schizophrenia in adult patients who are clinically stable on monthly paliperidone palmitate injections.
- The non-inferiority of 3-monthly injections of paliperidone palmitate compared with monthly injections has been demonstrated, without improvement in safety or quality of life.
- TREVICTA is to be used only after the patient has been adequately treated with 1-monthly paliperidone palmitate injections, preferably for four months or more, in situations where spacing of the injections would not be detrimental to the patient’s regular monitoring, which is at least monthly and which is not limited to the single administration of the medicinal product
Clinical Added Value
|no clinical added value||
Évaluation des médicaments