Sycrest(asenapine)

Sycrest (asenapine) is indicated for the treatment of Bipolar I disorder. Efficacy in reducing manic symptoms over 3 weeks was demonstrated, and the maintenance of effect during the episode was adequately shown. The benefit of combination treatment with a mood-stabiliser was sufficiently established. However, the clinical significance of the treatment effect in short-term studies A7501004 and A7501005 was modest, and efficacy was found to be inferior compared to Olanzapine in these studies. Efficacy for asenapine as a treatment for Bipolar I disorder was adequately demonstrated.

Regulatory review documents indicate a CHMP positive opinion date of 24 June 2010, with the European Commission decision adoption date on 1 September 2010, granting the marketing authorisation for Sycrest in bipolar I disorder. A post-approval commitment for a dose-finding study was made. The CHMP benefit-risk balance for bipolar I disorder was positive, while for schizophrenia it was negative.

Pharmacological safety findings include 5-HT2A receptor blocking activity (ED50) at 0.075 mg/kg and 0.001 mg/kg, α2 adrenergic receptor blocking activity (ED50) at 0.085 mg/kg, and dopaminergic neurone activity blocking (ED50) at 0.040 mg/kg. The recommended dose range is 5 mg to 10 mg twice daily.