Keranetics, LLC — Department of Defense SBIR Phase II: A14-048

Description

This Phase II project is relevant to the medical product research goals of the Department of Defense given the prevalence of complex burn wounds that cause both acute and chronic pain. The current solution for burn-related pain is the administration of systemic opioid drugs, which have significant side effects and are highly addictive. A potential solution to this problem is localized, topical delivery of analgesics directly to the wound site via a burn dressing. In the Phase I project, KeraStat hydrogels demonstrated the ability to deliver opioids in a mouse model to provide topical analgesia. Further, these opioid-loaded KeraStat hydrogels provided sustained pain relief when compared to topical treatment with the opioid alone, demonstrating the effectiveness of the delivery system. Given the proof of in vivo efficacy from the Phase I project, this Phase II project seeks to confirm in vivo testing in a rat burn model using the most promising formulation of KeraStat + morphine. In addition, this project will complete the necessary toxicity and pharmacokinetic studies required by the FDA for an IND submission (drug-device combination product regulated by CDER) to begin human testing in Phase III of the project.