A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder

Key Inclusion Criteria

• Male or female participants at least 18 years of age at the time of informed consent
• Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
• Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
• Participant is willing and able to comply with study procedures and visit schedule
• i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions

Key Exclusion Criteria

• Diagnosis other than GAD that is the primary focus of treatment
• Clinically significant psychiatric or medical condition that may interfere with study participation
• Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes
• Clinically significant abnormal laboratory values or ECG findings
• Significant suicide risk
• Substance use/positive drug screen
• Use of prohibited medications/therapies
• Known sensitivity to SEP-363856