Bridge Therapeutics, Inc. is an innovative development-stage pharmaceutical company pursuing FDA and EMA approval of a patented (U.S. Patent #8410092) drug combination, BT-205, for the treatment of chronic pain in opioid-experienced patients.
This two-component compound has the potential to be a new treatment option for healthcare providers around the world, and to offer patients an alternative chronic pain therapy.
The lead drug product, BT-205, was discovered and patented by Dr. Sullivan, et al. in 2005. Bridge Therapeutics is pursuing FDA approval through the 505(B)(2) process. BT-205 is a unique combination of two chronic pain drugs delivered (administered) in a state-of-the-art sublingual formulation. The dosing and delivery method will be a commercial advantage over the current alternatives. Bridge Therapeutics’ goal is to make the BT-205 compound and other investigational new drug candidates available to millions of patients in which opioids are ineffective or unsatisfactory.
The 505(B)(2) approval process is a hybrid between a 505(J) ANDA and a 505(B)(1) NDA. 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.
“Bridge is partnering with Camargo Pharmaceutical Services, the industry experts in providing comprehensive drug development services.“