DRGT Completes a Pivotal Phase I Trial; Results Confirm 6X Faster Attainment Of Maximum Plasma Levels For Pain Management Compared To Currently Available COX-2 Inhibitor
The pharmacokinetic profile for DRGT-46 was evaluated in adult subjects after a single 100-mg (30 min to Tmax) or 200-mg (45 min to Tmax) dose of DRGT-46 compared to a single 200-mg (180 min to Tmax) Celebrex® dose. There were no significant safety issues and all adverse effects were mild and unrelated to study drugs. “This phase 1 study demonstrates the enhanced absorption, earlier Tmax, and up to 6-times earlier attainment of therapeutic plasma concentrations of celecoxib with DRGT-46 compared to the branded product, Celebrex®,” said John Friend M.D., Chief Medical Officer for DRGT-USA. “We are working to initiate a pivotal phase 3 program in adults with acute pain and continuing to explore other development options for both adult and pediatric populations.”
DRGT-46 is designed to enhance the absorption rate for celecoxib, leading to faster attainment of therapeutic plasma concentrations to provide more rapid and consistent pain relief. DRGT-46 dissolves easily into 100-200 ml tap water for oral administration, and taste profile testing confirmed patient preference for DRGT-46. Celecoxib (Celebrex®) is a nonsteroidal anti-inflammatory inhibitor of cyclooxygenase-2 (COX-2) available in capsule form that is indicated for management of acute pain, osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, and juvenile idiopathic arthritis (JIA).
DRGT is a specialty pharmaceutical company dedicated to the development and commercialization of high-value proprietary drugs that deliver measurable and meaningful improvements in clinical utility. DRGT utilizes its proprietary Super-API drug development platform to rapidly select, screen and develop drugs with enhanced pharmacokinetics which could lead to improved efficacy and safety. Super-APIs are proprietary drug compositions that are developed by DRGT’s drug development platform comprising the Compound(s) molecularly dispersed in a supramolecular polymer(s) and/or excipient(s) matrix. The Company’s Super-API portfolio contains 30 compounds across a variety of indications and are protected by global composition of matter Intellectual Property. The company was founded by Dr. Ferenc Darvas, who is also the Chairman of the oldest Hungarian upstream-technology network.
Celebrex® is a registered product of Pfizer
DRGT Technologies Holdings has no ownership interest in Pfizer
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