Bridge Therapeutics, Inc. is a development-stage pharmaceutical company pursuing FDA approval of BT‑219 for Opioid Use Disorder (OUD), and BT-205 for the treatment of chronic pain in opioid-experienced patients.
BT-219, or Bunalz™, is an investigational new drug applying Catalent’s Zydis® orally disintegrating tablet delivery technology (ODT) to buprenorphine and naloxone, which are the active ingredients in Suboxone®. Catalent’s proprietary Zydis® technology is a unique, freeze-dried, sublingual dosage form that offers several advantages to other formulations currently on the market. Bridge Therapeutics is pursuing FDA approval through the 505(B)(2) process.
Bridge Therapeutics is pursuing FDA approval through the 505(B)(2) process for both therapies. The 505(B)(2) approval process for is a hybrid between a 505(J) ANDA for generics and a 505(B)(1) NDA for new chemical entities (NCEs). This regulatory pathway allows a drug to be approved using safety and efficacy studies already in the public domain. This can result in a much faster and less expensive route to approval. Bridge is partnering with Camargo Pharmaceutical Services, the industry-leading experts in providing comprehensive drug development services specialized for the 505(B)(2) approval pathway and analogous European processes. BT-219 and BT-205 will use this pathway.
BT-205 is a novel combination of buprenorphine and meloxicam intended for opioid-experience patients with moderate to severe chronic pain (U.S. Patent #8410092).
BT-205, was developed and patented by Dr. Sullivan, et al. in 2005. BT-205 is a unique combination of two chronic pain drugs delivered via a state-of-the-art sublingual formulation. Its active ingredients, dosing and delivery method should provide significant advantages over traditional opioids. Bridge Therapeutics seeks to make BT-205 and other investigational new drug candidates available to millions of patients for whom opioids are ineffective or unsatisfactory. FDA approval will also follow the 505(B)(2) process.
“Bridge is partnering with Camargo Pharmaceutical Services, the industry experts in providing comprehensive drug development services.“