Non-Opioid Post-Operative Pain Management Using Bupivacaine-loaded Poly(ester urea) Mesh

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.