BIRMINGHAM, Ala., November 7, 2019 (Newswire.com) - 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. Based on the FDA’s written response to our meeting request, Bridge has decided to proceed with executing the overall new product development plan presented to FDA incorporating suggestions received for seeking an NDA for BT-219 in the coming months.
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®. Catalent’s proprietary Zydis® technology is a unique, freeze-dried, sublingual dosage form and offers administration advantages.
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.
A Pre-IND meeting provides an opportunity for open communication between the sponsor and the FDA to discuss the IND development plan and to obtain the agency’s guidance for clinical studies for eventual regulatory approval.
About Opioid Dependence
Opioid Addiction is a national emergency with 130 Americans dying every day on average from an opioid overdose.1Opioids have the potential to cause substance dependence that is characterized by a strong desire to take opioids, impaired control over opioid use, persistent opioid use despite harmful consequences, a higher priority given to opioid use than to other activities and obligations, increased tolerance, and a physical withdrawal reaction when opioids are discontinued. There are effective treatments for opioid dependence yet less than 10% of people who need such treatment are receiving it.2
About Bridge Therapeutics
Bridge Therapeutics is an innovative, late-development-stage specialty pharmaceutical company pursuing FDA approvals of its investigational drugs BT-205 and BT-219. BT-205 is a patented (U.S. Patent #8410092) drug combination for the treatment of chronic pain in opioid-experienced patients. BT-205 is a unique combination of two chronic pain drugs — the partial-agonist opioid buprenorphine and the NSAID meloxicam. Also under development is BT-219, a state-of-the-art formulation of Buprenorphine and Naloxone for the treatment of opioid dependence. BT-219 utilizes Catalent’s Zydis® Orally Disintegrating Tablet (ODT) technology. Bridge Therapeutics’ goal is to help combat the opioid crisis by making its treatments available for use.
1) Understanding the Epidemic. Atlanta, GA: CDC, National Center for Injury Prevention and Control; 2018. Available at https://www.cdc.gov/drugoverdose/epidemic/index.html
2) Information Sheet on Opioid Overdose. World Health Organization; 2018, Available at https://www.who.int/substance_abuse/information-sheet/en
Source: Bridge Therapeutics Inc.