FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sunovion Earns Breakthrough Designation for Schizophrenia Treatment

May 20, 2019
A A

Sunovion received a breakthrough therapy designation from the FDA for its investigational EP-363856 for the treatment of patients with schizophrenia.

The company believes the drug has the potential to be the first agent for the treatment of schizophrenia that is not a dopamine 2 receptor antagonist.

In Phase 2 studies, patients treated with SEP-363856 showed statistically significant improvement compared with those who received the placebo and the treatment was generally well tolerated.

View today's stories