VALDOXAN (agomelatine), antidepressant
PSYCHIATRY - Focus
Opinions on drugs - Posted on Apr 18 2016
Reason for request
Renewal of Inclusion
No clinical benefit demonstrated in the treatment of major depressive episodes in adults.
- VALDOXAN has Marketing Authorisation in the treatment of major (i.e. clear) depressive episodes in adults.
- Its efficacy is modest and has been demonstrated only in the short term (6-12 weeks) versus placebo. It has not been shown to have any impact on the remission rates for depressive episodes, the primary efficacy endpoint. Its use necessitates strict monitoring of liver function before the initiation of and throughout the treatment.
Improvement in actual benefit
Évaluation des médicaments