Quetiapine Fumarate

NEW HAVEN, Conn., May 21, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that Rob Risinger, M.D., Chief Medical Officer of Neuroscience, will deliver oral and poster presentations at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The meeting will take place May 28 to 31, 2024 in Miami Beach, FL. ASCP presentation details are below: Oral Presentation Title: An Exploratory Comparison of Sublingual Dexmedetomidine with Quetiapine in Healthy Elderly Subjects Date/Time: May 28, 2024, 2:20-2:30 p.m. ET Location: Salon 3 Poster Presentation Title: Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of BXCL501 with Concomitant Treatment with Anti-Depressant in Healthy Volunteers Date/Time: May 29, 2024, 11:15 a.m.-1:00 p.m. ET Location: Salon 4 Poster Presentation Title: A Phase Ib/II Multicenter, Randomized, Double Blind, Placebo-Controlled, Ascending Dose Finding Study of BXCL501 in Agitation Associated with Dementia Date/Time: May 30, 2024, 12:30-2:15 p.m. ET Location: Salon 4 About BXCL501 In indications other than those approved by the U.S. Food and Drug Administration (FDA) as IGALMI™ (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BioXcel Therapeutics believes that BXCL501 potentially targets an important mediator of agitation, and the Company has observed anti-agitation results in multiple clinical trials across several neuropsychiatric disorders. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with dementia due to probable Alzheimer’s disease and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. AboutIGALMI™(dexmedetomidine)sublingualfilm INDICATION IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IMPORTANTSAFETYINFORMATION IGALMIcancauseserioussideeffects,including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure,andolderpatients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI. Withdrawalreactions,tolerance,anddecreasedresponse/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. Themostcommonsideeffects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201- 1088 or medinfo@bioxceltherapeutics.com. Please see full Prescribing Information. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. Forward-LookingStatements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to the Company’s planned participation in and content of the Company’s presentations at the ASCP Annual Meeting. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at . These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. ContactInformation Corporate BioXcel Therapeutics Erik Kopp 1.203.494.7062 ekopp@bioxceltherapeutics.com Investor Relations BioXcel Therapeutics Brennan Doyle 1.475.355.8462 bdoyle@bioxceltherapeutics.com Media Russo Partners David Schull 1.858.717.2310 David.schull@russopartnersllc.com Scott Stachowiak 1.646.942.5630 Scott.stachowiak@russopartnersllc.com Source: BioXcel Therapeutics, Inc. IGALMI™ is a trademark of BioXcel Therapeutics, Inc. BT BIOXCEL THERAPEUTICS is a registered trademark of BioXcel Therapeutics, Inc. All other trademarks are the properties of their respective owners. Copyright © 2024, BioXcel Therapeutics, Inc. All rights reserved.

Warning letters can safely cut prescribing of a powerful but risky antipsychotic, according to a new study. Researchers used Medicare data to study the effects of the letters on hundreds of thousands of older adults with dementia. They found a significant and lasting reduction in prescribing but no signs of adverse effects on patient health. Warning letters from Medicare can safely cut prescribing of a powerful but risky antipsychotic, according to a new study at Columbia University Mailman School of Public Health. Researchers used Medicare data to study the effects of the letters on hundreds of thousands of older adults with dementia. They found a significant and lasting reduction in prescribing but no signs of adverse effects on patient health. The findings are published in JAMA Network Open. "Our study shows that low-cost letter interventions can safely reduce antipsychotic prescribing to patients with dementia," said Adam Sacarny, PhD, assistant professor of Health Policy and Management at Columbia Mailman School. The work was conducted with researchers at the London School of Economics, Harvard T.H. Chan School of Public Health and Johns Hopkins University. The researchers evaluated a large trial in which Medicare sent warning letters to high prescribers of quetiapine, the most popular antipsychotic in the U.S. Antipsychotics are frequently prescribed to people with dementia, but can cause numerous harms in this group. Researchers therefore studied the hundreds of thousands of older adults with dementia who were treated by the prescribers in the trial. Most previous studies on reducing prescribing in dementia care consisted of small trials or observational analyses, with limited evidence from large-scale randomized studies. The results were striking. "People with dementia living in nursing homes and in the community were prescribed less and we did not detect negative health impacts for these groups," said Michelle Harnisch, research student at the London School of Economics and first author of the study. The findings are important because antipsychotics, such as quetiapine, are often used in dementia care to address behavioral symptoms. About 1 in 7 nursing home residents receives an antipsychotic every quarter. However, the drugs have a number of well-known risks. These include weight gain, cognitive decline, falls, and death. In turn, physician specialty societies, government regulators, and policymakers have aimed to reduce prescribing of these medications to people with dementia. To test whether the warning letters reduced prescribing safely, the researchers used administrative data from Medicare to link the 5,055 physicians in the original trial to the Medicare records of their patients with dementia. They ultimately analyzed 84,881 patients in nursing homes and 261,288 patients living in the community. The intervention reduced quetiapine use among nursing home patients by 7 percent and community-dwelling patients by 15 percent. The researchers did not find adverse effects across numerous health outcomes, including cognitive function, behavioral symptoms, depression, or metabolic outcomes like diabetes. There were signs of improved mental health outcomes, and the risk of death for patients living in the community fell slightly. This research follows up on the original evaluation of the warning letters. In that study, members of the same research team also showed that the letters reduced prescribing. However, they focused on a considerably smaller sample of patients and studied a limited set of health outcomes. In contrast, the new research evaluates a number of key health indicators for dementia care and substantially expands the patient sample with a focus on dementia. "These results show that this intervention and others like it could be leveraged to make prescribing safer and improve dementia care" noted Sacarny. "Similar interventions could also be adapted to other contexts to promote high-quality care." Co-authors are Michael L. Barnett, Stephen Coussens, Kali S. Thomas, Mark Olfson, and Kiros Berhane. The study was supported by the National Institute on Aging (R21-AG070942).