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In adults with schizophrenia and bipolar I or II disorder,

THE SERENITY I AND II TRIALS EVALUATED IGALMI FOR THE ACUTE TREATMENT OF AGITATION1

Identically designed, randomized, placebo-controlled, parallel-group, fixed-dose trials comparing placebo to two active arms

SERENITY I and II randomized agitated patients with schizophrenia or bipolar I or II disorder in 3 arms (placebo, 180 mcg, 120 mcg) SERENITY I and II randomized agitated patients with schizophrenia or bipolar I or II disorder in 3 arms (placebo, 180 mcg, 120 mcg)

Trial endpoints:

  • Primary endpoint: Change from baseline in the Positive and Negative Syndrome Scale-Excited Component (PEC) score at 2 hours following initial dosing

  • Key secondary endpoint: Time to effect onset as measured by the change from baseline in the PEC score following initial dosing

PEC is a validated, investigator-rated tool to assess agitation severity across five main items1,2

Excitement
• Uncooperativeness
• Tension
• Poor impulse control
• Hostility

Each item is rated on a scale of 1 (absent) to 7 (extremely severe). The total PEC score is calculated by taking the sum of the individual items.1-3

Agitation severity based on total PEC scores: mild agitation (5-13), moderate agitation (14-19), or severe agitation (20-35) Agitation severity based on total PEC scores: mild agitation (5-13), moderate agitation (14-19), or severe agitation (20-35)

A PEC score of ≥14, with at least one individual item score of ≥4, was required for enrollment1

As shown by baseline characteristics, a broad range of patients were included1

Baseline characteristics for the patients enrolled in SERENITY I and SERENITY II Baseline characteristics for the patients enrolled in SERENITY I and SERENITY II Baseline characteristics for the patients enrolled in SERENITY I and SERENITY II Baseline characteristics for the patients enrolled in SERENITY I and SERENITY II

In each trial, demographic and baseline disease characteristics were comparable across placebo and IGALMI treatment arms.1,4,6

IMPORTANT SAFETY INFORMATION

INDICATION

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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypotension, Orthostatic Hypotension, and Bradycardia: IGALMI causes dose-dependent hypotension, orthostatic hypotension, and bradycardia. In clinical studies with IGALMI, patients were excluded if they had treatment with alpha-1 noradrenergic blockers, benzodiazepines, other hypnotics or antipsychotic drugs four hours prior to study drug administration; had a history of syncope or syncopal attacks; SBP < 110 mmHg; DBP < 70 mmHg; HR < 55 beats per minute; or had evidence of hypovolemia or orthostatic hypotension. Because IGALMI decreases sympathetic nervous system activity, hypotension and/or bradycardia may be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in geriatric patients. Avoid use of IGALMI in patients with hypotension, orthostatic hypotension, advanced heart block, severe ventricular dysfunction, or history of syncope. After IGALMI administration, patients should be adequately hydrated and should sit or lie down until vital signs are within normal range. If a patient is unable to remain seated or lying down, precautions should be taken to reduce the risk of falls. Ensure that a patient is alert and not experiencing orthostatic hypotension or symptomatic hypotension prior to allowing them to resume ambulation.

IGALMI is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Limitations of Use: The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose.

QT Interval Prolongation: IGALMI prolongs the QT interval. Avoid use of IGALMI in patients at risk of torsades de pointes or sudden death, including those with known QT prolongation, a history of other arrhythmias, symptomatic bradycardia, hypokalemia, or hypomagnesemia, and in patients receiving other drugs known to prolong the QT interval.

Somnolence: IGALMI can cause somnolence. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or operating hazardous machinery, for at least eight hours after taking IGALMI.

Risk of Withdrawal Reactions, Tolerance, and Tachyphylaxis: IGALMI was not studied for longer than 24 hours after the first dose. There may be a risk of physical dependence, a withdrawal syndrome, tolerance, and/or tachyphylaxis if IGALMI is used in a manner other than indicated.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were somnolence, oral paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension.

DRUG INTERACTIONS

Drugs That Prolong the QT Interval: Avoid use. Concomitant use of drugs that prolong the QT interval may add to the QT-prolonging effects of IGALMI and increase the risk of cardiac arrhythmia.

Anesthetics, Sedatives, Hypnotics, and Opioids: Concomitant use may cause enhanced CNS-depressant effects. Reduction in dosage of IGALMI or the concomitant medication should be considered.

USE IN SPECIFIC POPULATIONS

Hepatic Impairment and Geriatric Patients (≥65 years old): A lower dose is recommended in patients with hepatic impairment and geriatric patients. See the full Prescribing Information for the recommended dosage depending on the agitation severity.

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact BioXcel Therapeutics, Inc. at 1-833-201-1088 1-833-201-1088 or medinfo@bioxceltherapeutics.com, or FDA at 1-800-FDA-10881-800-FDA-1088 or www.fda.gov/medwatch.

References:

1. IGALMI. Package insert. BioXcel Therapeutics, Inc.; 2022. 2. Montoya A, Valladares A, Lizán L, San L, Escobar R, Paz S. Validation of the excited component of the positive and negative syndrome scale (PANSS-EC) in a naturalistic sample of 278 patients with acute psychosis and agitation in a psychiatric emergency room. Health Qual Life Outcomes. 2011;9(18):1-11. doi:10.1186/1477-7525-9-18 3. Martinez-Raga J, Amore M, Di Sciascio G, et al. 1st international experts’ meeting on agitation: conclusions regarding the current and ideal management paradigm of agitation. Front Psychiatry. 2018;9:54. doi:10.3389/fpsyt.2018.00054 4. Data on file. BXCL501-301 CSR (SERENITY I). BioXcel Therapeutics, Inc.; January 2021. 5. Data on file. BXCL501-301 Table 14.2.1.1 (SERENITY I). BioXcel Therapeutics, Inc.; October 2020. 6. Preskorn SH, Zeller S, Citrome L, et al. Effect of sublingual dexmedetomidine vs placebo on acute agitation associated with bipolar disorder: a randomized clinical trial. JAMA. 2022;327(8):727-736. doi:10.1001/jama.2022.0799 7. Data on file. BXCL501-302 CSR (SERENITY II). BioXcel Therapeutics, Inc.; January 2021.