Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department

Inclusion Criteria: English speaking adults age ≥18 years Patients with an established diagnosis of (1) bipolar I disorder, (2) bipolar II disorder, (3) schizophrenia, (4) schizoaffective disorder, or (5) schizophreniform disorder Judged to be clinically agitated at the time of Screening and Baseline with a AMSS ≥2 Able to read, understand, and provide written informed consent Subject judged to be likely capable of self-administration of BXCL501 sublingually or buccally Exclusion Criteria: Likely to be discharged, admitted, or transferred from the ED within 6 hours after study medication administration Administration of benzodiazepines or antipsychotic drugs in the 2 hours before study treatment Treatment with alpha-1 noradrenergic antagonists Female patients who are pregnant or are breastfeeding Hypotension (systolic blood pressure <100 mmHg or diastolic blood pressure <60 mmHg) and/or bradycardia (heart rate <55 beats per minute) at the time of Screening or Baseline evaluation History of dysautonomia Patient with a known diagnosis of familial long QT syndrome, second degree or third degree atrioventricular block without pacemaker, or sick sinus syndrome Patients with serious or unstable medical illnesses determined by the study investigators or qualified designees Patients with history of allergic reactions to dexmedetomidine Patients previously enrolled and completed the current study Patients actively enrolled in other ED-based studies involving pharmacological or behavioral interventions