BRIEF—Breakthrough designation for novel schizophrenia drug

US-based Sunovion Pharmaceuticals, a subsidiary of Japan’s Sumitomo Dainippon, has received Breakthrough Therapy designation for its investigational SEP-363856, for the treatment of people with schizophrenia.

Data from Phase II trials show a statistically significant improvement compared with placebo, and a good safety profile.

The company is seeking approval for what would be the first therapy in this indication that is not a dopamine 2 receptor antagonist.