Following a full submission
aripiprazole oral formulations (Abilify) are not recommended for use within NHS Scotland for the treatment of moderate to severe manic episodes in bipolar 1 disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.
Aripiprazole demonstrated superior efficacy to placebo in reducing manic symptoms at week 3 and treatment effect comparable to lithium or haloperidol was maintained at week 12.
Aripiprazole also demonstrated superior efficacy to placebo in prevention of relapse. It has not been compared to other atypical antipsychotics in this indication.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.
The licence holder has advised their intention to resubmit.
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Medicine details
- Medicine name:
- aripiprazole (Abilify)
- SMC ID:
- 498/08
- Indication:
- for the treatment of moderate to severe manic episodes in bipolar I disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic epis
- Pharmaceutical company
- Bristol-Myers Squibb Pharmaceuticals Ltd
- BNF chapter
- Central nervous system
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 08 September 2008