BERWYN, PA — Virpax® Pharmaceuticals, Inc. (NASDAQ: VRPX) has unveiled hopeful results from its Maximum Tolerated Dose (MTD) study of Probudur™, a long-acting pain management drug, in Sprague-Dawley rats. Probudur, an injectable formulation of liposomal bupivacaine, is designed to significantly reduce or eliminate opioids’ necessity after surgery by providing extended pain relief directly at the wound site.
The innovative drug works by blocking pain signals from reaching the brain, offering pain control for up to five days in animal models, and showing a slow release of the active ingredient for as long as six days in lab studies. The recent study aimed to identify the maximum tolerated dose of Probudur, comparing it against both a free form of bupivacaine and a combination of the two, with findings suggesting Probudur’s superior safety profile and effectiveness in pain management.
Notably, the study found that Probudur was well-tolerated across all dosages, without significant impact on body weight, clinical chemistry, hematology, or coagulation. Additionally, bupivacaine showed less toxicity when delivered in liposomal form compared to its free form, highlighting the benefits of Probudur’s liposomal delivery system.
Histopathological examination of the injection sites revealed minimal to moderate changes, marginally more pronounced at higher doses of Probudur, confirming its relative safety. These findings underscore Probudur’s potential as a safer alternative to free bupivacaine, offering a better therapeutic window.
Virpax Pharmaceuticals’ CEO, Gerald Bruce, expressed optimism regarding the study’s outcomes, emphasizing Probudur’s capacity for immediate and sustained pain relief after a single injection. “These results confirm our belief that Probudur is well-tolerated in animals and a single injection of this proprietary liposomal formulation of bupivacaine has the potential to provide both immediate relief as well as sustained relief at the wound site,” Bruce remarked.
The successful completion of this MTD study brings Virpax Pharmaceuticals closer to filing an Investigational New Drug Application (IND) for Probudur, marking a significant step towards reducing opioid dependency in post-surgical pain management. This development is particularly crucial in the context of the ongoing opioid crisis, offering hope for safer, more effective pain control options.
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