Merck Sharpe and Dohome receives positive opinion on Sycrest

Merck Sharpe and Dohme has been given a recommendation for European approval of Sycrest, its new tablet-based treatment for bipolar I disorder.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the treatment’s marketing authorisation application based on findings from a clinical study programme.

These trials indicated that the drug is effective in lessening the occurrence of moderate to severe manic episodes associated with the disorder, when compared to placebo.

Sycrest has been approved for this specification under the name Saphris in the US since August 2009.

Dr Armin Szegedi, head of psychiatry, neuroscience clinical research at Merck Sharpe and Dohme, said: “We are pleased that, pending a final [European] Commission decision, physicians in European markets may have a new option to help their patients manage the symptoms of bipolar I disorder.”

Last week, Merck Sharpe and Dohme highlighted results from a trial of its chemotherapy-induced nausea and vomiting treatment fosaprepitant dimeglumine, illustrating the drug’s safety and efficacy.