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The Department of Health & Human Services has issued guidance to do away with the so-called X-waiver, a move the agency said will increase the number of providers able to deliver medication-assisted treatment and therefore increase patient access to care. “The medical evidence is clear: access to medication-assisted treatment, including buprenorphine that can be prescribed…

“Companies with limited R&D resources can forgo costly and more risky discovery and development of new chemical entities and instead make incremental innovations to existing drugs. In this manner, companies can use the 505(b)(2) regulatory pathway to repurpose or reposition drugs for new indication,” notes Dr. Babul. A 505(b)(2) NDA may differ from a previously…

Dr. David Fiellin, Director of Yale Program in Addiction Medicine, said, “For individuals who come to an emergency department after an opioid overdose and receive buprenorphine, their one-year mortality rate falls by 40%”. The increased recognition of the benefits of buprenorphine comes at a critical time, the researchers said.  

The pandemic has led to regulatory changes: Treatment can now be entirely virtual, including the first appointment. Medicare now pays providers the same for a video appointment as a conventional one — many insurers and Medicaid programs have followed. Patients can get a month’s prescription for buprenorphine instead of just a week’s. Forty percent of…

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…

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…

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…

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…

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,…

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…