Press Releases

The latest press releases 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 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….

21st September 2018

Pharmaceutical startup Bridge Therapeutics announces the addition of Dr. Bob Raffa as its newest Scientific Advisory Board member. Dr. Raffa is a global leader in pharmacology, with over 40 years of preclinical research on drug abuse and analgesic drug discovery. He has held many prestigious leadership roles, including Co-Leader for analgesic drug discovery at Johnson…

4th September 2018

Dr. Greg Sullivan, Chief Scientific Officer, Dr. Dave Bergstrom. Chief Operations Officer, and Tim Peara of will be speaking about how Bridge Therapeutics’ lead investigational drug could be a key part of ending the opioid crisis. Each year 70 million Americans will take an opioid for pain. Of these, 17 million take a strong opioid…

19th July 2018

Executives with the innovative late development-stage pharmaceutical startup, Bridge Therapeutics, announced they will be introducing their chronic pain development program at the American Chronic Pain Association (ACPA) Roundtable. The ACPA offers peer support and education in pain management skills to people with chronic pain, along with their families, friends, and healthcare professionals. Alton Kelley, Director…

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