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LIKOZAM (clobazam), benzodiazepine
PSYCHIATRY - New medicinal product
Opinions on drugs -
Posted on
Jan 13 2017
Reason for request
Inclusion
Insufficient clinical benefit in the short-term symptomatic treatment of excitation and agitation in patients with schizophrenia or other psychotic disorders.
- LIKOZAM has Marketing Authorisation in patients with schizophrenia or other psychotic disorders, in the short-term management of symptoms of excitation and agitation.
- In the absence of data, the role of clobazam in therapeutic use cannot be specified.
- This Committee does not recommend inclusion on the list of reimbursable products for this indication.
No clinical advantage demonstrated relative to URBANYL (clobazam in tablets), in the short-term symptomatic treatment of anxiety that is severe, disabling or responsible for an unacceptable state of distress, including anxiety states associated with affective disorders.
- LIKOZAM has Marketing Authorisation in the short-term (2-4 weeks) symptomatic treatment of anxiety that is severe, disabling or responsible for an unacceptable state of distress.
- In this indication, it must be used in combination with adequate treatments for the underlying disorder.
- Without a comparative study, there was no demonstrable clinical benefit compared with other anxiolytics.
No clinical benefit demonstrated in the treatment of partial or generalised epilepsy in patients over 2 years of age, in case of failure of 2 consecutive monotherapies.
- LIKOZAM has Marketing Authorisation, in combination with another antiepileptic treatment, in adults or children over 2 years of age, when treatment with one of more antiepileptics is ineffective: treatment of simple or complex partial epilepsies, with or without secondary generalisation and treatment of all types of generalised epilepsy (tonic-clonic seizures, myoclonic seizures, absence seizures).
- Without a comparative study, there was no demonstrable clinical benefit compared with other antiepileptics. The oral suspension form of clobazam has a particular benefit in patients for whom the tablet form is not suitable as well as in patients over 6 years of age.
Clinical Benefit
| Substantial |
- |
| Insufficient |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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