News

The latest news and views from bridge therapeutics
27th April 2020

Birmingham, AL – April 27, 2020 – Bridge Therapeutics Inc. heard today from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application No.142396 for the Company’s lead product candidate, BT-219 (Bunalz™) is “Open and Safe to Proceed”. There were no additional questions or constraints included in the FDA’s communication. Opening…

25th March 2020

Birmingham, AL – March 25, 2020 – Bridge Therapeutics Inc. today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company’s lead product candidate, BT-219 (Bunalz™). BT-219, or Bunalz™, is an investigational new drug applying Catalent’s Zydis® ODT (orally disintegrating tablet) delivery technology…

17th February 2020

Birmingham, AL – February 17, 2020 – Late last year Bridge Therapeutics Inc. (“Bridge”) completed the manufacture of clinical trial materials under Good Manufacturing Practices (GMP) at Catalent Pharmaceutical Services (“Catalent”) to use in the upcoming initial human pharmacokinetic (PK) clinical study.  Subsequent to manufacture, these supplies were successfully released by Quality Assurance for use…

10th December 2019

Catalent today announced that it has completed clinical production of Bridge Therapeutics Inc.’s (Bridge) opioid addiction development therapeutic product, BT-219, and executed an Exclusive Licensing Agreement to use Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology Catalent’s Zydis ODT technology is a unique, freeze-dried tablet that disperses almost instantly in the mouth without water. Zydis…

7th November 2019

Bridge Therapeutics Inc. today announced that it has received feedback from the Food and Drug Administration (FDA) from a Pre-Investigational New Drug (PIND) meeting for the development of BT-219, a therapy to treat Opioid Dependence.  BT-219, or Bunalz™, is an investigational new drug applying Catalent’s Zydis® ODT (orally disintegrating tablet) delivery technology to buprenorphine and naloxone,…

2nd October 2019

Dr. Michael Kittay is a Harvard-trained psychiatrist certified by the American Board of Addiction Medicine. In this article Dr. Kittay discusses how buprenorphine can greatly reduce deaths from opioid addiction.  September 6, 2019  Dr. Kittay writes “In March 2019, a report to Florida’s attorney general recognized MAT [Medically Assisted Therapy] as a key component of…

1st February 2019

The case for buprenorphine in the treatment of opioid addiction is overwhelming, yet stigmas and biases still remain leading to inadequate treatment of those battling addiction. “Basing medical decisions on beliefs about medications does nothing to help the growing pool of those with [opioid use disorder], who if untreated are likely to fall victim to…

2nd November 2018

As their newest member, Dr. Bob Rappaport brings decades of drug approval experience to Bridge Therapeutics’ Scientific Advisory Board. Dr. Rappaport spent 20 years at the Food and Drug Administration, with the last 12 years as Director of the Anesthesia, Analgesia, and Addiction Products Division at the Center for Drug Evaluation and Research. There he…

31st October 2018

Bridge Therapeutics will present a poster presentation at the RESI Conference November 4, 2018, in New York. Bridge Therapeutics has been selected by Life Science Nation’s internal scientific review board to be part of the Innovation Challenge presenting its technology in an exhibition-style format throughout the full-day RESI Conference on November 4, 2018, in New York….

18th October 2018

Ruth Potee, M.D., of Greenfield, Mass., said that when buprenorphine first became available in 2002, there was an expectation that it would be widely used in primary care because addiction is a chronic condition. “By 2010, only 2 percent of primary care physicians were prescribing it,” she said. “That was a massive failure.” Dr. David…