SBIR-STTR Award

This Phase I project is relevant to the goals of this program announcement given the prevalence of complex burn wounds that cause both acute and chronic pain. The current solution to burn-related pain is the administration of systemic opioid pain drugs, which have significant side effects and are highly addictive. Recently, it has been shown that localized delivery of opioids can alleviate pain without the associated risks of systemic delivery; however, no reliable carrier has been identified thus far. An ideal carrier would both act as a wound dressing and provide sustained release of the analgesic. A solution to this problem is to use a keratin hydrogel burn wound dressing (KeraStat?) that has been shown to be an effective drug delivery vehicle for the topical delivery of antibiotics and other drugs. This Phase I project seeks to test the feasibility of using KeraStat to provide local, topical extended release of commonly used pain drugs. The studies proposed here will test the release kinetics of several formulations of analgesic-loaded KeraStat. The most promising formulations will then be tested in a mouse paw pain model for pilot efficacy. Together these data, along with data from rheometry performed on the loaded hydrogels, will form the basis for Phase II small and large animal efficacy studies in models relevant to burn pain.

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.