Advice

Following a full submission

agomelatine (Valdoxan) is not recommended for use within NHS Scotland for the treatment of major depressive episodes in adults.

When used in a flexible dosing schedule, agomelatine significantly reduced the symptoms of depression and increased the number of patients who responded to treatment compared with placebo. There are limited comparative data against existing antidepressants and the results of such comparisons are variable.

The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

The licence holder has indicated their intention to resubmit.

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Medicine details

Medicine name:
agomelatine (Valdoxan)
SMC ID:
564/09
Indication:
Major depressive episodes
Pharmaceutical company
Servier Laboratories Ltd
BNF chapter
Central nervous system
Submission type
Full
Status
Not recommended
Date advice published
09 November 2009