Dexmedetomidine

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

Retrieved on: 
Monday, February 5, 2024

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

Retrieved on: 
Monday, December 11, 2023

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)

Retrieved on: 
Monday, November 6, 2023

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

Retrieved on: 
Monday, October 30, 2023

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

Retrieved on: 
Wednesday, October 4, 2023

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

Retrieved on: 
Monday, September 4, 2023

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.

BTAI DEADLINE ALERT: ROSEN, SKILLED 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

Retrieved on: 
Saturday, September 2, 2023

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.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of BioXcel Therapeutics, Inc. - BTAI

Retrieved on: 
Friday, September 1, 2023

NEW YORK, Sept. 01, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI).

Key Points: 
  • NEW YORK, Sept. 01, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether BioXcel and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

ROSEN, A LEADING AND TOP RANKED LAW FIRM, Encourages BioXcel Therapeutics, Inc. Investors with Losses to Secure Counsel Before Important September 5 Deadline in Securities Class Action – BTAI

Retrieved on: 
Saturday, August 26, 2023

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.
  • WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles.
  • 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.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of BioXcel Therapeutics, Inc. - BTAI

Retrieved on: 
Saturday, August 26, 2023

NEW YORK, Aug. 26, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI).

Key Points: 
  • NEW YORK, Aug. 26, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether BioXcel and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.