Posters & Publications
The following is a listing of the posters presented by BioXcel from select congresses and is not intended to be a complete overview of all congresses, congress materials and clinical information. Please select “REQUEST A COPY OF POSTER(S) OR PUBLICATION(S)” below if you would like to receive a copy of any of these posters or publications from Medical Affairs. These materials may include information that is inconsistent with the product’s Prescribing Information (PI). BioXcel Therapeutics does not suggest or recommend the use of products in any manner other than as described in the Pl.
- SERENITY I: Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial
- SERENITY II: Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial
- Agitation Associated with Schizophrenia or Bipolar Disorder: Sublingual Dexmedetomidine Film Efficacy by Baseline Agitation Level: Psych Congress 2023
- Number Needed to Treat (NNT) and Number Needed to Harm (NNH) from Two Phase 3 Studies of Sublingual Dexmedetomidine for Treating Acute Agitation in Patients with Schizophrenia and Bipolar Disorder: NEI 2022
- Sublingual Dexmedetomidine for the Treatment of Acute Agitation Associated with Schizophrenia or Bipolar Disorder: Effect Size and Pooled Efficacy: ACLP 2022
- Dexmedetomidine Sublingual Film for Treatment of Acute Agitation Associated With Schizophrenia or Bipolar Disorder: SERENITY I and SERENITY II Trials: APNA 2022
- Sublingual Dexmedetomidine Reduction in Agitation Across Baseline Severity in Patients With Bipolar Disorders: ISBD 2022
- Dexmedetomidine Sublingual Film for Acute Agitation Associated With Schizophrenia or Bipolar Disorder: Pooled Clinical Trial Data: SAEM 2022
- Dexmedetomidine Sublingual Film: Post Hoc Analysis of PANSS-Excited Component Items in Acute Agitation Associated With Schizophrenia or Bipolar Disorder: APA 2022
- Safety, Acceptability, and Pharmacokinetics of Dexmedetomidine Orally Dissolving Film (BXCL501) for Treating Acute Agitation in Patients with Schizophrenia: ASHP 2021
- BXCL501 data in agitation associated with bipolar disorder by mood state: ISBD 2021
- Effect of BXCL501 for Treating Acute Agitation in Patients with Bipolar Disorder: ISBD 2021
- Pharmacokinetics of Dexmedetomidine after a Single Sublingual Dose of BXCL501 in Patients with Agitation Associated with Schizophrenia: ISBD 2021
- Safety and Patient Acceptability of BXCL501 for Treating Acute Agitation in Patients with Bipolar Disorder: ISBD 2021
- A Novel Treatment of Agitation for Schizophrenia with the Oral Dissolving Film BXCL501: APA 2021
-
Novel Treatment of Agitation in Patients with Bipolar Disorders:
BXCL501 - An Oral Dissolving Film: APA 2021
- Treatment and Economic Challenges when Treating Patients with Agitation Associated with Schizophrenia or Bipolar Disorder in the Emergency Department: AAEP NUBE 2023
- Real-world Pilot Survey of Clinical Experience Using Dexmedetomidine Sublingual Film for Acute Agitation in Adults with Schizophrenia or Bipolar Disorder: CSHP 2023
- Direct Medical Cost-Estimator Tool – Economic Burden of Physically Restrained Patients with Agitation and Bipolar Disorder in Emergency Departments: ISBD 2023
- Clinical Characteristics of Patients with Agitation Episodes Associated with Bipolar Disorder or Schizophrenia –Real World Patient Journey: ISPOR 2023
- Real World Impact of Patients with Bipolar Disorder or Schizophrenia who Experience High Frequency (HF) of Agitation Episodes: AMCP 2023
- Clinical Management of Acute Agitation in Patients with Schizophrenia or Bipolar Disorder in Emergency Departments in the United States –A Retrospective Chart Review: ASHP 2022
- Characterization of Patients With Acute Agitation and Schizophrenia Treated in Emergency Departments in the United States: A Retrospective Chart Review: AMCP 2022
- Direct Medical Cost-Estimator Tool –Economic Burden of Physically Restraining Patients with Agitation and Schizophrenia in Emergency Departments: ISPOR 2022
- Characterization and Charges of Emergency Department Encounters and Restraints in Patients with Acute Agitation and Schizophrenia or Bipolar Disorder Using Nationwide Emergency Department Sample Data: ASHP 2021
- Estimating the Prevalence of Acute Agitation Associated with Schizophrenia and Bipolar Disorder Resulting in Emergency Department Visits in the US: AMCP 2021
- Epidemiology of Acute Agitation Secondary to Schizophrenia and/or Bipolar Disorder in Patients Presenting to Emergency Departments: A Systematic Literature Review: ISPOR 2021
IMPORTANT SAFETY INFORMATION
IGALMI is self-administered under the supervision of a healthcare provider. A healthcare provider should monitor vital signs and alertness after IGALMI administration to prevent falls and syncope.
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.
INDICATION
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
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 or medinfo@bioxceltherapeutics.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
