Development of a novel sustained release local anesthetic wound dressing for partial-thickness dermal injuries

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PROJECT SUMMARY The pain associated with superficial and partial-thickness dermal wounds can be intense and sustained throughout the healing process. Inadequate pain management can impair wound healing, prolong hospitalization, decrease patient satisfaction and increase healthcare costs. Due to limited treatment options and the short duration of current local anesthetic formulations, opioid analgesics are the mainstay of pain management for these patients despite their association with a variety of adverse events. Consequently, pain from dermal injury is not optimally treated because providers lack a safe and effective alternative to opioids for their patients. 109 Therapeutics is developing BUPIVADERM, a novel, drug-delivering wound dressing that provides sustained bupivacaine delivery to partial-thickness dermal wounds in a predictive and extended manner. The novel wound dressing will be a first-of-kind wound dressing that provides both the wound healing properties of the traditional moist wound dressings clinically available, but with the added functionality of safe and effective analgesia for 5 days. The dressing will only need to be applied one time and non-traumatically peels off once re-epithelialization occurs, thus eliminating the need for dressing changes or analgesic redosing. The novel wound dressing will provide significant value to patients, clinicians, and society alike by increasing patient satisfaction, mitigating the use of opioids, and reducing cost of care in the treatment of partial-thickness dermal wounds. In preliminary experiments, we have demonstrated the ability to fabricate bupivacaine-loaded microporous polymer films that have the same dimensions and physicochemical properties of the current gold standard moist wound dressings, but with the added ability to provide 5 days of sustained bupivacaine delivery. The proposed work will seek to demonstrate in vivo technical feasibility of the novel wound dressing by validating the safety, wound healing and analgesic efficacy of our prototype in a standardized porcine dermal injury model. Analgesic efficacy and duration will be assessed by von Frey assay of mechanical sensitivity, wound healing will be assessed via gross and histological assays, and systemic toxicity will be assessed via pharmacokinetic assessment. The proposed Phase I work will demonstrate that our novel sustained bupivacaine release wound dressing can provide 5 days of safe and effective non-opioid analgesia and non-inferior wound healing in a clinically relevant pre-clinical model, which would warrant continuation of commercialization efforts.