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SATIVEX (delta-9-tetrahydrocannabinol/cannabidiol), analgesic
NEUROLOGY - New medicinal product
Opinions on drugs -
Posted on
Nov 20 2014
Reason for request
Inclusion
No clinical benefit demonstrated in the treatment of spasticity due to multiple sclerosis
- SATIVEX is a mixture of two cannabis extracts with Marketing Authorization in the treatment of symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who are responders to an initial treatment.
- This is a symptomatic adjuvant treatment in patients who are not sufficiently relieved by standard anti-spasticity treatments.
- Efficacy on a spasticity score was observed in approximately 10% of patients insufficiently relieved by an optimal anti-spastic treatment.
Clinical Benefit
| Low |
the actual benefit of SATIVEX is low in the Marketing Authorisation indication. |
Clinical Added Value
| no clinical added value |
Given the reservations resulting from the level of evidence in the performed studies and the small levelof the effect observed, the Committee considers that SATIVEX does not provide an improvement in actual benefit (IAB V,none) in the treatment of symptoms related to moderate to severe spasticity due to multiple sclerosis. |
