11/07/19 Bridge Therapeutics Announces It Will Seek FDA Approval for BT-219, a Treatment for Opioid Dependence in the Coming Months
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 BunalzTM, is an investigational new drug applying Catalent’s Zydis® ODT (orally disintegrating tablet) delivery technology to buprenorphine and naloxone, which are the active ingredients in Suboxone®. The FDA has reviewed Bridge’s Clinical, non-Clinical and Chemistry, Manufacturing, and Controls overall development plan and agrees with Bridge’s proposed 505(b)(2) regulatory submission pathway. The feedback from the FDA will facilitate the preparation and submission of the IND in the very near future.