27th April 2020
Investigational New Drug (IND) Application Now Open for BT-219 for Opioid Dependence
Birmingham, AL – April 27, 2020 – Bridge Therapeutics Inc. heard today from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application No.142396 for the Company’s lead product candidate, BT-219 (Bunalz™) is “Open and Safe to Proceed”. There were no additional questions or constraints included in the FDA’s communication.
Opening the IND allows Bridge to import the drug from Catalent in England and to conduct a pharmacokinetic (PK) clinical study to demonstrate bio-equivalence with its Listed Drug (LD).
BT-219, or Bunalz™, is an investigational new drug applying Catalent’s Zydis® ODT (orally disintegrating tablet) delivery technology of 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.
“Bridge is very pleased to have this IND opened, since it allows us to conduct a PK study of Bunalz.” remarked Bridge’s President, Tim Peara, MBA.
The IND is a major milestone within the 505(b)(2) approval pathway that Bridge is pursuing. The 505(b)(2) abbreviated FDA approval pathway greatly expedites the approval of drugs consisting of active ingredients that have been previously approved by the FDA. This pathway allows a drug’s developer to rely on the FDA’s determination of the safety and efficacy of previously approved medications in order to avoid the cost of repeating preclinical and clinical work and to shorten the time for FDA review and approval.
About Opioid Dependence
Opioid Addiction is a national emergency with 130 Americans dying every day on average from an opioid overdose.1 Opioids 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 them.2
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
About Bridge Therapeutics
Bridge Therapeutics is an innovative, late-development-stage specialty pharmaceutical company pursuing FDA approvals of its investigational drugs BT-219 and BT-205. BT-219 is 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. Also under development is BT-205, a patented (U.S. Patent #8410092) drug combination for the treatment of chronic pain in opioid-experienced patients. BT-205 combines two chronic pain drugs — the partial-agonist opioid buprenorphine and the non-steroidal anti-inflammatory drug (NSAID) meloxicam. Bridge Therapeutics’ goal is to help combat the opioid crisis by making its treatments available for use.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit https://www.catalent.com
More products. Better treatments. Reliably supplied.™
About Camargo Pharmaceutical Services
Founded in 2003, Camargo Pharmaceutical Services is a leading global development and commercialization partner to large and small biotech and pharmaceutical companies, with a proven ability to help bring life-changing therapies to the market faster and more cost-effectively.
Camargo is established as one of the recognized experts and industry leaders in designing complex, customized development strategies, including those utilizing the FDA 505(b)(2) approval pathway. The company is passionate about the client’s success and the differences it can make in the lives of others. Camargo’s global reach and client base extends to more than 25 countries.