asenapine (Sycrest)

Following a full submission

asenapine (Sycrest®) is not recommended for use within NHS Scotland.

Indication under review: treatment of moderate to severe manic episodes associated with bipolar I disorder, in adults.

Asenapine when used as monotherapy demonstrated superior efficacy to placebo in reducing manic symptoms as measured using the Young Mania Rating Score at three weeks with maintenance of effect at 12 weeks. In addition, asenapine in combination with lithium or valproate demonstrated superior efficacy to lithium or valproate monotherapy.  There are no direct comparative data when asenapine is used as add-on treatment.  Indirect comparisons with other second generation antipsychotic agents used as monotherapy and as adjunctive therapy suggested equivalent efficacy.

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

The licence holder has indicated their intention to resubmit.