Phase II Amount
$1,730,751
21MedTech, LLC is developing SERENZATM, a non-opioid analgesic that is released from a bioresorbable filmfor post-surgical pain management. Post-surgical pain management is a significant contributor to the risk foropioid addiction and diversion. There were nearly 129 million outpatient surgeries in the U.S. in 2018 andorthopedic surgeons alone account for nearly 8% of all opioid prescriptions in the U.S. Though the risk foraddiction 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 theongoing opioid crisis. There have been several products and therapies attempting to provide non-opioidpostoperative pain relief, but these products only work for 24 to 48 hours, despite claims otherwise, and othersstill require additional rescue medication. To meet this urgent need, we are developing SERENZA. SERENZA isa polymer film loaded with local anesthetic that is implanted at the surgical site following operation. Tunableformulation of the film and loading enable control over local release for pain relief for up to four days followingsurgery. The polymer film is bioresorbable and safely degrades over time. We have demonstrated safety of ourpolymer film carrier, efficacy of the drug, and proof-of-concept of our system in vivo. Our Phase II objectives areto optimize drug release kinetics and develop manufacturing standards, determine effective dosage for retentionof motor function, and determine safety and efficacy in mouse neuropathic pain models. Completion of thesegoals will progress SERENZA toward first in-human clinical trials and successful FDA approval. Successfulapproval and commercialization of SERENZA will enable a powerful new strategy for providers to reduce orpotentially eliminate the use of opioids and the risk of opioid use disorder for patients following surgery.
Public Health Relevance Statement: 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.
Project Terms: Adhesions ; Ambulatory Surgical Procedures ; Ambulatory Surgery ; Outpatient Surgery ; Amino Acids ; aminoacid ; Pain management ; Pain Control ; Pain Therapy ; pain treatment ; Local Anesthetics ; Conduction-Blocking Anesthetics ; Animals ; Non-Steroidal Anti-Inflammatory Agents ; NSAIDs ; Non Steroidal Antiinflammatory Agents ; Nonsteroidal Anti-Inflammatory Agents ; Nonsteroidal Antiinflammatory Agents ; Nonsteroidal Antiinflammatory Drug ; non-steroidal anti-inflammatory drugs ; non-steroidal antiinflammatory drugs ; nonsteroidal anti-inflammatory drugs ; Bupivacaine ; Clinical Trials ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Esters ; Limb structure ; Extremities ; Limbs ; Non-Trunk ; Goals ; Cyclic GMP ; Guanosine Cyclic Monophosphate ; cGMP ; Hernia ; Hydrocodone ; Dihydrocodeinone ; Hycodan ; Hycon ; In Vitro ; Kinetics ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Medical Device ; Mus ; Mice ; Mice Mammals ; Murine ; Orthopedics ; Orthopedic ; Orthopedic Surgical Profession ; Oxycodone ; Dihydrohydroxycodeinone ; Oxycodeinon ; Oxycodone SR ; Oxycontin ; Roxicodone ; Pain ; Painful ; Postoperative Pain ; Post-operative Pain ; pain after surgery ; post-surgical pain ; postsurgical pain ; Patients ; Drug Kinetics ; Pharmacokinetics ; Polyesters ; Polymers ; Postoperative Period ; Post-Operative ; Postoperative ; Public Health ; Risk ; Safety ; sciatic nerve ; Time ; Tissues ; Body Tissues ; United States ; Urea ; Carbamide ; Elaqua XX ; Urea Carbamide ; Ureaphil ; Work ; Drug Delivery Systems ; Drug Delivery ; Film ; Injury ; injuries ; base ; dosage ; Label ; improved ; Acute Pain ; Procedures ; Site ; Acute ; repaired ; repair ; Residual state ; Residual ; Phase ; soft tissue ; Recovery ; diabetic ; Product Approvals ; Licensing ; Opioid ; Opiates ; non-opioid analgesic ; non-narcotic analgesic ; non-opiate analgesic ; non-opioid ; non-opioid therapeutics ; nonnarcotic analgesics ; nonopiate analgesic ; nonopioid ; nonopioid analgesics ; Therapeutic ; Exposure to ; Absence of sensibility to pain ; Feels no pain ; No sensitivity to pain ; analgesia ; Absence of pain sensation ; Intravenous ; Hour ; Oral ; Source ; System ; Opiate Dependence ; opioid addiction ; opioid dependence ; opioid dependent ; Opiate Addiction ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Surgeon ; innovative technologies ; copolymer ; stoichiometry ; bioresorbable polymer ; degradable polymer ; biodegradable polymer ; drug efficacy ; Toxicities ; Toxic effect ; Reporting ; controlled release ; Modeling ; Cardiac Toxicity ; Cardiotoxic ; Cardiotoxicity ; Provider ; Inflammatory Response ; Thickness ; Thick ; Address ; Dose ; Data ; Motor ; in vivo ; Monitor ; Development ; developmental ; painful neuropathy ; neuropathic pain ; novel strategies ; new approaches ; novel approaches ; novel strategy ; Trauma ; innovation ; innovate ; innovative ; Implant ; mouse model ; murine model ; stem ; addiction ; addictive disorder ; commercialization ; high risk ; combat ; standard of care ; mechanical allodynia ; Sterilization ; prescription opioid ; licit opioid ; opiate medication ; opioid medication ; prescribed opiate ; prescribed opioid ; prescription opiate ; operation ; opioid use disorder ; opiate use disorder ; Formulation ; opioid use ; opiate consumption ; opiate drug use ; opiate intake ; opiate use ; opioid consumption ; opioid drug use ; opioid intake ; experimental study ; experiment ; experimental research ; opioid policy ; opioid guideline ; opioid law ; opioid legislation ; opioid epidemic ; opiate crisis ; opioid crisis ; pain model ; pain relief ; relieve pain ; first-in-human ; first in man ; opioid overuse ; safety assessment ; drug release profile ; drug release kinetics ; drug release rate ; chronic pain management ;
