Sunovion and PsychoGenics Initiate DIAMOND Phase 3 Clinical Studies for SEP-363856 in the Treatment of Adults and Adolescents with Schizophrenia
SUMITOMO CHEM UNSP/ADR (SOMMY)
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Source: Business Wire
— First patient in the global Phase 3 program enrolled —— Approximately one in 100 adults and one in 1,000 adolescents in the United States are living with schizophrenia 1 — MARLBOROUGH, Mass. & PARAMUS, N.J.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) and PsychoGenics Inc. (PsychoGenics), today announced the initiation of the DIAMOND (Developing Innovative Approaches for Mental Disorders) Phase 3 studies for SEP-363856, a novel agent for the treatment of adults and adolescents with schizophrenia. The global, multicenter program includes four studies that are designed to evaluate the safety, efficacy and tolerability of SEP-363856. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for SEP-363856 in May 2019.SEP-363856 does not block dopamine 2 (D2) or serotonin 2A (5-HT2A) receptors in vivo, which are thought to mediate the effects of currently available antipsychotic medicines. Although the exact mechanism of action requires
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