Bunalz

Bunalz (BT-219) is an investigational combination drug developed by Bridge Therapeutics for the treatment of opioid use disorder (OUD). It is a sublingual, orally disintegrating tablet (ODT) formulation containing buprenorphine and naloxone, the same active ingredients as Suboxone. Buprenorphine acts as a partial agonist at the mu-opioid receptor to mitigate withdrawal symptoms and cravings, while naloxone serves as an opioid antagonist to deter intravenous misuse. The drug utilizes Catalent's proprietary Zydis technology for rapid dispersion in the mouth without water, aiming to improve treatment adherence and reduce medication diversion. Bridge Therapeutics is pursuing FDA approval via the 505(b)(2) regulatory pathway.