Merck Sharpe and Dohme granted EU approval for Sycrest

Merck Sharpe and Dohme has received approval from European regulators for the sale of Sycrest as a treatment for manic episodes among bipolar I disorder sufferers.

The European Commission has granted authorisation to the sublingual tablet-based therapy based on the recommendation of the European Medicines Agency Committee for Medicinal Products for Human Use, following a review of clinical data.

During a number of short-term studies, use of the drug was shown to be associated with a superior reduction of manic symptoms over three weeks when compared to placebo.

The treatment may now play a vital role in helping bipolar disease patients to control their mania, resulting in a more stable mood and a reduced likelihood of serious complications.

Dr Armin Szegedi, head of psychiatry and neuroscience clinical research at Merck, said: "Today's approval provides a new treatment for patients in Europe that is intended to help address the needs of one of the most serious mental illnesses."

Earlier this month, the company also received permission from European regulators to launch its new atrial fibrillation drug Brinavess, which has been developed in partnership with Cardiome Pharma.