Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

Exclusion Criteria

• •Patients with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, or hematologic disease.
• •A history of agitation episodes due to substance use.
• •A diagnosis of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder that predated the diagnosis of schizophrenia or bipolar disorder
• •Patients who are judged to be at significant risk of suicide
• •Female patients who have a positive pregnancy test at Screening or Baseline, or are breastfeeding.
• •Patients currently treated with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin), alpha-2 adrenergic agonists, or other prohibited medications.
• •Patients with hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease, or focal neurological findings.
• •History of syncope or other syncopal attacks, current evidence of hypovolemia, or orthostatic hypotension
• •Patients with laboratory or ECG abnormalities considered clinically significant by the Investigator
• •Patients who have received an investigational drug within 30 days before the study start
• •Patients who have previously received BXCL501 via prescription (under the trade name IGALMI™) or received BXCL501 in clinical trial
• •Patients considered by the Investigator to be unsuitable candidates for receiving dexmedetomidine or considered to be unsuitable for participating in the study for any reason.
• •Part 1 only
• •Patients with agitation caused by acute intoxication, including identification of alcohol by breathalyzer or drugs of abuse (except for THC) during urine screening.
• •Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 4 hours before study treatment.
• •Part 2 only
• •Psychiatric comorbidities are generally allowed; however, moderate or severe substance use disorders (SUD) (within the past 6 months) are exclusionary if the substance involved is other than nicotine or caffeine. Cannabis use is not exclusionary if it is not the focus of treatment in the last 6 months before Screening.
• •Self-injurious behavior that is active.
• •Patients with known personal or family history of genetic long QT syndrome.
• •Has known the patient for at least 3 months cumulatively.
• •Currently living with or routinely contacting the patient at least five days a week.
• •Does not plan to discontinue contact with the patient during the study period.
• •Willing and able to provide written informed consent.
• •Willing and able to follow the study procedures, including completing the Agitation Episode Diary and other study procedures during the study.
• •Willing and able to accompany patient and remain present at the clinical site during the clinic visits and be interviewed by the Investigator.