21MedTech LLC — Department of Health and Human Services SBIR Phase II: 300

Description

SUMMARY 21MedTech, LLC is developing SERENZATM, a non-opioid analgesic that is released from a bioresorbable film for post-surgical pain management. Post-surgical pain management is a significant contributor to the risk for opioid addiction and diversion. There were nearly 129 million outpatient surgeries in the U.S. in 2018 and orthopedic surgeons alone account for nearly 8% of all opioid prescriptions in the U.S. Though the risk for addiction and diversion is high, there are currently few alternative options to opioids for the management of post- surgical pain and new approaches are needed to reduce patient exposure to these drugs and improve the ongoing opioid crisis. There have been several products and therapies attempting to provide non-opioid postoperative pain relief, but these products only work for 24 to 48 hours, despite claims otherwise, and others still require additional rescue medication. To meet this urgent need, we are developing SERENZA. SERENZA is a polymer film loaded with local anesthetic that is implanted at the surgical site following operation. Tunable formulation of the film and loading enable control over local release for pain relief for up to four days following surgery. The polymer film is bioresorbable and safely degrades over time. We have demonstrated safety of our polymer film carrier, efficacy of the drug, and proof-of-concept of our system in vivo. Our Phase II objectives are to optimize drug release kinetics and develop manufacturing standards, determine effective dosage for retention of motor function, and determine safety and efficacy in mouse neuropathic pain models. Completion of these goals will progress SERENZA toward first in-human clinical trials and successful FDA approval. Successful approval and commercialization of SERENZA will enable a powerful new strategy for providers to reduce or potentially eliminate the use of opioids and the risk of opioid use disorder for patients following surgery.PROJECT NARRATIVE There is an urgent need to develop non-opioid postoperative pain management solutions. In this project, we are developing a bioresorbable drug delivery product that can release controlled amounts of non-opioid analgesic over time to manage pain for several days following surgery. Continued development and successful FDA approval of this product will reduce or eliminate the need for opioids postoperatively. This will significantly reduce patient exposure to these drugs and stem the ongoing opioid crisis while providing safe and effective pain relief.