17th February 2020
Bridge Therapeutics Demonstrates Formulation Stability of its Opioid Addiction Treatment
Birmingham, AL – February 17, 2020 – Late last year Bridge Therapeutics Inc. (“Bridge”) completed the manufacture of clinical trial materials under Good Manufacturing Practices (GMP) at Catalent Pharmaceutical Services (“Catalent”) to use in the upcoming initial human pharmacokinetic (PK) clinical study. Subsequent to manufacture, these supplies were successfully released by Quality Assurance for use in the upcoming PK trial having met predetermined release criteria.
An additional requirement for administering an experimental pharmaceutical to humans is to demonstrate physical and chemical stability of the product throughout the course of the human study. Consequently, a formal stability study was commissioned evaluating the stability of the product at time zero, 1-month, 3-months and 1-year.
Recently, analytical assessment of the 1-month stability of Bridge’s BT-219 therapy was completed with satisfactory results. Bridge’s Chief Operating Officer, David H Bergstrom, PhD, commented, “This is a significant milestone in that it demonstrates acceptable product characteristics and thus supports moving ahead with the planned human PK study in the very near future.”
BT-219, or Bunalz™, is an investigational new drug (IND) which applies Catalent’s Zydis delivery technology to buprenorphine and naloxone, which are the active ingredients in the Suboxone® prescription medication for opioid addiction. Buprenorphine, being a Schedule III medication, is considered safer and less addictive than methadone, which is classified as a Schedule II medication. It has also been shown that buprenorphine is six-times safer than methadone with regard to overdose risk among the general population.1
Quality Assurance within the pharmaceutical industry is both a business process and a line function. Quality Assurance reviews and formally approves the analytical results from Quality Control to ensure all pre-established criteria are met in order to release the product for use in humans.
As a requirement for FDA approval, at least 12 months of real time stability data is required before stocking pharmacies for commercial sale. Pending prior agreement with FDA, a new drug application (NDA) may be submitted with only 6 months stability data. https://bmjopen.bmj.com/content/5/5/e007629
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
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