Birmingham, AL – March 25, 2020 – Bridge Therapeutics Inc. today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company’s lead product candidate, BT-219 (Bunalz™).

BT-219, or Bunalz™, 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.

This IND marks an important step in the approval process since, after allowing a 30-day period for the FDA to consider the application so as to determine that the proposed study may safely proceed, BT-219 can then be imported and tested in humans. Based on the FDA’s response to Bridge’s Pre-IND meeting last October, the key and perhaps only clinical work required for submission of a New Drug Application (NDA) for BT-219 would be a pharmacokinetic (PK) study to demonstrate the bioequivalence of BT-219 with its Listed Drug (LD).

“It’s great to see all the hard work done by Bridge and its regulatory partner Camargo come together in this IND,” 
commented Bridge’s Chief Operating Officer and lead on the IND preparation, David H Bergstrom, PhD.

An IND registers a medication with the FDA and requests permission to conduct a study in human subjects. The FDA reviews safety data, the clinical study design, and the Chemistry, Manufacturing, and Controls (CMC) for the drug formulation to be studied. Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical studies. This time allows the FDA to review the IND for any unacceptable risks to research subjects which, if found, would lead the FDA to impose a clinical hold. Note, the pre-IND that Bridge presented last year was meant to identify such concerns and allow them to be addressed in the design of the clinical studies proposed by this IND.

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.

Bridge’s regulatory partner Camargo Pharmaceuticals, a leading expert in the 505(b)(2) approval pathway, has been working closely with Bridge to ensure the application’s completeness and accuracy.

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.

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.

Media Contact:
Alton Kelley
Phone: 877-223-6949
Email: alton@bridgerx.net