MSD’s Sycrest (asenapine) has been approved for marketing authorisation by the European Commission.

The decision on the treatment for bipolar disorder in adults was based on recommendations from the Committee for Medicinal Products for Human Use (CHMP) and efficacy data.

Eduard Vieta, Professor of Psychiatry at the University of Barcelona and Director of the Bipolar Disorders Program of the Hospital Clinic, Barcelona, welcomed the move saying it offered ‘a new option’ for patients.

Sycrest joins AstraZeneca’s Seroquel, Eli Lilly’s Zyprexa and J&J’s Risperdal as approved bipolar disorder treatments.

Clinical trials, which included nearly 1,300 patients, showed Sycrest demonstrated superior efficacy in the reduction of manic symptoms over a three-week period. Only one in ten suffered any related side-effects.

“Bipolar I disorder is difficult to manage, and patients frequently discontinue therapy for a variety of reasons,” said Eduard Vieta. “Having multiple treatment options is vital for patients, and asenapine represents a new option for this serious disease.”

The sublingual tablet is marketed as Saphris in the US.