Sumitomo Pharma's Class 1 new drug for schizophrenia was approved for clinical use

Article source: Pharmaceutical Guanlan

According to the latest announcement by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, Sumitomo Dainippon Pharma's Class 1 new drug SEP-363856 tablets have obtained four clinical trials with implied approval, and it is planned to develop the treatment of schizophrenia.

Screenshot source: CDE official website

Schizophrenia is a chronic and serious mental illness that affects more than 23 million people worldwide.

SEP-363856 is a new type of trace amine-related receptor 1 (TAAR1) agonist with serotonin 1A (5-HT1A) agonist activity.

At present, the therapeutic effect of SEP-363856 has been initially verified in clinical trials.

Compared with placebo, after 4 weeks of treatment, in terms of the Positive and Negative Symptom Scale (PANSS, a medical scale used to measure the severity of symptoms in patients with schizophrenia), the flexible dose of SEP-363856 once a day ( 50-75 mg) treatment showed a statistically significant and clinically significant improvement; at the same time, according to the evaluation of the clinical overall impression-severity scale (CGI-S, clinical evaluation of mental illness), patients receiving SEP-363856 treatment The overall severity of the disease has also improved; in addition, a 6-month open-label extension study showed that SEP-363856 has good safety and tolerability.

Note: The original text has been deleted

Reference

[1] Center for Drug Evaluation (CDE) of China National Medical Products Administration.