Dexmedetomidine

BioXcel Therapeutics Announces Plan for Evaluating BXCL501 in the At-Home Setting to Expand Its Market Potential

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月曜日, 4月 22, 2024
FDA, Patient, Dexmedetomidine, Safety, Agitation, Food, Bipolar disorder, Intermittent explosive disorder, Intelligence, Schizophrenia, Medicine, New product development, DSM-IV codes, Therapy, Type, Pharmaceutical industry

NEW HAVEN, Conn., April 22, 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 additional details regarding the planned design of its SERENITY At-Home Phase 3 trial*to evaluate BXCL501, the Company’s investigational, proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with bipolar disorders or schizophrenia in the home setting. The Company’s plan to conduct this trial using a 120 mcg dose is based on feedback received from the U.S. Food and Drug Administration (FDA) following the recent receipt of agency minutes from the Type C meeting held on March 6, 2024.

Key Points: 
  • The outpatient trial is expected to enroll a total of approximately 200 patients with agitation associated with bipolar disorder or schizophrenia.
  • Patients will self-administer 120 mcg of BXCL501 or placebo when agitation episodes occur over the trial period.
  • The primary objective is safety with efficacy measures as exploratory endpoints to evaluate use in the outpatient setting.
  • A corporate presentation, including information on the SERENITY program, is available on the Investors section of the Company’s website: bioxceltherapeutics.com.

BioXcel Therapeutics Announces TRANQUILITY In-Care Pivotal Phase 3 Trial Plan With BXCL501 for Agitation Associated With Alzheimer’s Dementia

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水曜日, 4月 10, 2024
FDA, Dexmedetomidine, Safety, Agitation, Food, Dementia, Intelligence, Live, Patient, AAD, Medicine, New product development, Database, Positive, Therapy, Type, Pharmaceutical industry

NEW HAVEN, Conn., April 10, 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 details regarding the planned design of its upcoming TRANQUILITY In-Care Phase 3 trial to evaluate BXCL501, the company’s investigational proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with Alzheimer’s dementia (AAD) in the care setting. The Company’s plan to conduct this trial is based on feedback received from the U.S. Food and Drug Administration (FDA), following the recent receipt of minutes from the Type B/Breakthrough Therapy designation meeting held with the agency on February 20, 2024.

Key Points: 
  • “The design of our upcoming TRANQUILITY In-Care trial largely mirrors TRANQUILITY II, which demonstrated positive efficacy and safety results with a 60 mcg dose of BXCL501,” said Vincent O’Neill, M.D., Chief of Product Development and Medical Officer of BioXcel Therapeutics.
  • “We have completed two recent meetings with the FDA on our TRANQUILITY program, and are pleased to have obtained clarity on the next steps for our AAD development path.
  • The trial is expected to enroll patients with episodic agitation, with patients self-administering 60 mcg of BXCL501 or placebo when agitation episodes occur over the trial period.
  • A slide presentation on the TRANQUILITY program is available on the Investors section of the Company’s website: bioxceltherapeutics.com.

BioXcel Therapeutics Announces European Patent Office’s Grant of Patent for Method of Treating Agitation in Dementia Using Sublingual Dexmedetomidine

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金曜日, 3月 15, 2024
The Orange Book, Agitation, Patent, Intelligence, Patient, Tablet, Heel, EPO, Orange Book, Therapy, European Patent Convention, Dexmedetomidine, FDA, Dementia, Pharmaceutical industry

The 486 patent covers the use of dexmedetomidine administered sublingually to treat agitation in individuals with dementia.

Key Points: 
  • The 486 patent covers the use of dexmedetomidine administered sublingually to treat agitation in individuals with dementia.
  • The patent encompasses a broad range of dosage forms, including films such as BXCL501 (sublingual dexmedetomidine), wafers, and tablets, at dexmedetomidine doses ranging from 3 mcg to 100 mcg.
  • 17/496,470 with claims pertaining to methods of treating agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form.
  • The patent, when issued, is expected to have an expiration date of July 17, 2040, subject to patent term adjustment, patent term extension, and terminal disclaimers.

BioXcel Therapeutics Reports Financial Results for the Fourth Quarter and Full Year 2023

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火曜日, 3月 12, 2024
The Orange Book, Patent Cooperation Treaty, Agitation, Administration, Conference call, Type, PCT, Conference, Database, Schizophrenia, Intelligence, Caregiver, Webcast, Patient, DSM-IV codes, Neuroscience, Fast Track, Food and Drug Administration, CMC, Wind, Orange Book, SCNC, Positive, Microsatellite instability, Dexmedetomidine, Clinical trial, Therapy, Safety, Patent, Research and development, Collection, FDA, Approved drug, Dementia, CAD, Food, Pharmaceutical industry

NEW HAVEN, Conn., March 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today provided an update on its late-stage TRANQUILITY and SERENITY clinical programs. In addition, the Company reported its financial results for the fourth quarter and full year 2023.

Key Points: 
  • In addition, the Company reported its financial results for the fourth quarter and full year 2023.
  • Net Revenue: Net revenue from IGALMI was $376,000 for the fourth quarter of 2023, compared to $238,000 for the same period in 2022.
  • Net Loss: BioXcel Therapeutics had a net loss of $22.3 million for the fourth quarter of 2023, compared to a net loss of $54.8 million for the same period in 2022.
  • ET to provide an update on recent operational highlights and to discuss its fourth quarter and full year 2023 financial results.

BioXcel Therapeutics Announces USPTO’s Allowance of Patent Application for Method of Treating Agitation in Alzheimer’s Disease Using Oromucosal Formulations of Dexmedetomidine

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月曜日, 2月 5, 2024
Dexmedetomidine, Intelligence, Agitation, Patent, The Orange Book, Schizophrenia, Patient, PTE, Therapy, PTA, IP, Tablet, DSM-IV codes, Bipolar disorder, Pharmaceutical industry

NEW HAVEN, Conn., Feb. 05, 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 the United States Patent and Trademark Office (“USPTO”) has allowed U.S. Patent Application No. 17/496,470 with claims pertaining to a method of treating agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form. The broad claims encompass film formulations such as BXCL501 (sublingual dexmedetomidine), tablets, or wafers. The patent, when issued, is expected to have an expiration date of Dec. 29, 2037, subject to patent term adjustment (“PTA”), patent term extension (“PTE”), and terminal disclaimers.

Key Points: 
  • 17/496,470 with claims pertaining to a method of treating agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form.
  • The broad claims encompass film formulations such as BXCL501 (sublingual dexmedetomidine), tablets, or wafers.
  • The patent, when issued, is expected to have an expiration date of Dec. 29, 2037, subject to patent term adjustment (“PTA”), patent term extension (“PTE”), and terminal disclaimers.
  • The Company also announced that it has received an issue notification from the USPTO for U.S. Patent Application No.

BioXcel Therapeutics Strengthens Clinical Development Leadership to Advance Late-Stage Programs

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月曜日, 12月 11, 2023
Dexmedetomidine, Cardiology, Agitation, FDA, Roche, Actelion, Reata Pharmaceuticals, GSK, Pfizer, IND, Adamas, Medicine, Physician, University, Mount Sinai School, Schizophrenia, Doctor of Philosophy, MEK, Journal of Clinical Pathology, Intermittent explosive disorder, GSK plc, New product development, Caregiver, EMA, Therapy, Patient, Intelligence, Development, Senior, DSM-IV codes, Bipolar disorder, Sanofi, Royal college, Acquisition, Prostate cancer, Clinical trial, Biogen, Pharmaceutical industry

NEW HAVEN, Conn., Dec. 11, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced a key executive promotion and a clinical advisor appointment as part of the Company’s strategic reprioritization focused on the advancement of its late-stage clinical programs and emerging pipeline candidates.

Key Points: 
  • Vincent J. O’Neill, M.D., Senior Vice President and Chief Research & Development Officer of OnkosXcel Therapeutics, has been promoted to Executive Vice President, Chief of Product Development and Medical Officer of BioXcel Therapeutics.
  • Additionally, Rajiv Patni, M.D., has been appointed to the newly created position of Strategic Clinical Advisor to the BioXcel Therapeutics Chief Executive Officer and Board of Directors.
  • Prior to joining BioXcel Therapeutics, Dr. O’Neill held senior leadership roles at several leading global pharmaceutical companies, including Sanofi, Genentech, and GlaxoSmithKline.
  • “I look forward to working with the BioXcel leadership team in continuing to address the unmet medical needs of patients and caregivers and advance the Company’s product-development goals.”

BioXcel Therapeutics Announces Update on NIDA-funded Trial of BXCL501 (sublingual dexmedetomidine) for Potential Treatment of Opioid Use Disorder (OUD)

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月曜日, 11月 6, 2023
Post-traumatic stress disorder, FDA, Yale School of Medicine, Opioid use disorder, Standard of care, Intelligence, Government, Public Health Service Act, White House, Dexmedetomidine, Opioid epidemic, BID, Federal Food, Drug, and Cosmetic Act, Federation, Addiction, Xylazine, Psychiatry, COWS, Recreational drug use in Kenya, Locus coeruleus, Pharmacokinetics, OUD, National Institute on Drug Abuse, NIDA, Columbia University, NIH, Safety, Public, American Journal, Minneapolis Veterans Affairs Health Care System, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, Patient, Fentanyl, Bangladesh Technical Education Board, RTI International, United States Public Health Service, Pharmaceutical industry, Neuroscience

NEW HAVEN, Conn., Nov. 06, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced an update on the National Institute on Drug Abuse (NIDA)-funded trial evaluating BXCL501 (sublingual dexmedetomidine) as a potential treatment for opioid use disorder (OUD).

Key Points: 
  • NIDA has requested Columbia University, the trial coordinator, to add a fourth site to target trial completion in 2024.
  • After this time, BioXcel Therapeutics plans to seek FDA feedback on potential registrational paths.
  • “With BXCL501, we are excited about the potential to treat patients who are physically dependent on illicit and prescription opioids.
  • In addition to OUD as an indication, BioXcel Therapeutics has been awarded key opportunities for the development of BXCL501 in post-traumatic stress disorder and alcohol use disorder.

BioXcel Therapeutics Receives Permanent J-Code for IGALMI™ (dexmedetomidine) Sublingual Film from Centers for Medicare & Medicaid Services

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月曜日, 10月 30, 2023
Intermittent explosive disorder, Intelligence, HCPCS, Medicare, HCPCS Level 2, Dexmedetomidine, Bipolar II disorder, Schizophrenia, Healthcare Common Procedure Coding System, Agitation, Centers for Medicare & Medicaid Services, Therapy, CMS, Health insurance

NEW HAVEN, Conn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the Centers for Medicare & Medicaid Services (CMS) has issued a permanent and product-specific J-Code for IGALMI™ (dexmedetomidine) sublingual film, which is approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults1,2. Under the Healthcare Common Procedure Coding System (HCPCS) process, the IGALMI J-Code J1105 will become effective January 1, 2024.

Key Points: 
  • Under the Healthcare Common Procedure Coding System (HCPCS) process, the IGALMI J-Code J1105 will become effective January 1, 2024.
  • J-codes are permanent codes used by healthcare providers, commercial insurance plans, and government payers to help standardize the reimbursement process.
  • Compared to a miscellaneous or unlisted product code, a J-code simplifies claims submission, which in turn streamlines the billing and reimbursement process.
  • “Ultimately, we believe this commercial milestone will facilitate additional patient access to this important therapeutic option for the treatment of bipolar disorder- or schizophrenia-associated agitation.”

BioXcel Therapeutics Provides Update on Recent Developments for Late-Stage Clinical Programs and Expansion of IP Portfolio for IGALMI™ (dexmedetomidine) Sublingual Film

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水曜日, 10月 4, 2023
Patent, The Orange Book, Dexmedetomidine, Aes, Part, II, Agitation, Orange Book, Incidence, Dementia, Shanda, PEC, Live, Patient, Approved Drug Products with Therapeutic Equivalence Evaluations, Bipolar, Artificial intelligence, Security (finance), FDA, Therapy, Noa Pothoven, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, DSM-IV codes, Pharmaceutical industry, HAVEN, Schizophrenia

NEW HAVEN, Conn., Oct. 04, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience, today provided an update on recent developments with its late-stage clinical programs as well as its patent portfolio for IGALMI™ (dexmedetomidine) sublingual film. These developments include meetings scheduled with the U.S. Food and Drug Administration (FDA) to discuss the TRANQUILITY and SERENITY III clinical programs and the receipt of two Notices of Allowance (NOAs) from the U.S. Patent and Trademark Office to extend method of use patent protection for sublingual dexmedetomidine.

Key Points: 
  • “The meetings with the FDA are critical components of our business strategy.
  • The briefing book submitted to FDA for the meeting includes results from 11 double-blind, placebo-controlled Phase 2 and 3 clinical trials evaluating the safety and efficacy of BXCL501.
  • The Company now has four U.S. patents claiming formulations of dexmedetomidine with exclusivity until 2039 currently listed in the Orange Book.
  • These patents further broaden the scope of intellectual property estate for IGALMI™ and for future potential indications.

BTAI DEADLINE TOMORROW: ROSEN, TRUSTED INVESTOR COUNSEL, Encourages BioXcel Therapeutics, Inc. Investors With Losses in Excess of $100K to Secure Counsel Before Important September 5 Deadline in Securities Class Action – BTAI

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月曜日, 9月 4, 2023
Class Action Lawsuit, Professional Services, Legal, Titan, Institutional review board, Dexmedetomidine, Class, Record, Agitation, Dementia, Patient, Advertising, Court, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, I-Space (Chinese company), Food, Safety, Insurance, Tobacco

WHAT TO DO NEXT: To join the BioXcel Therapeutics class action, go to https://rosenlegal.com/submit-form/?case_id=17579 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the BioXcel Therapeutics class action, go to https://rosenlegal.com/submit-form/?case_id=17579 or call Phillip Kim, Esq.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.