Posted by Michael Wonder on 10 May 2019
Sunovion and PsychoGenics announce that SEP-363856 has received FDA breakthrough therapy designation for the treatment of people with schizophrenia
10 May 2019 - SEP-363856 offers an innovative approach to the treatment of schizophrenia including the potential to be the first agent for the treatment of schizophrenia that does not bind to dopamine 2 (D2) receptors.
Sunovion Pharmaceuticals and PsychoGenics today announced that the U.S. FDA has granted breakthrough therapy designation for SEP-363856, a novel agent for the treatment of people with schizophrenia.
The FDA granted breakthrough therapy designation for SEP-363856 based on pivotal, Phase 2 data from Study SEP361-201, which were presented by Sunovion at the 57th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in December 2018, as well as data from Study SEP361-202, a six-month, open-label, safety and tolerability extension study.
