Otsuka Pharmaceutical Development & Commercialization, Inc.
This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.
Key Inclusion Criteria 1. Male or female participants at least 18 years of age at the time of informed consent 2. Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention 3. Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856 4. Participant is willing and able to comply with study procedures and visit schedule 5. i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow pro…
Oral tablet
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