Business Decision

The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.

Key Inclusion Criteria:

1. Subjects must have successfully completed the parent study, BHV7000-204.
2. WOCBP must have a negative urine pregnancy test at Baseline visit.
3. WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.

Key Exclusion Criteria:

1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
2. Subjects who, in the opinion of the Investigator, will not be able to adhere to the Schedule of Assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study.
3. Investigator deems subject at imminent risk of danger to others or themself.