BERWYN, PA — Virpax® Pharmaceuticals, Inc. (NASDAQ: VRPX) recently announced initial positive results from a pilot study of its pain management drug candidate, Probudur™. The study was conducted under an existing Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR), a premier research organization dedicated to addressing trauma and critical care challenges in combat casualties.
The aim of the study was to ascertain whether Probudur can reduce pain behaviors in a rat model of incisional pain. Two different concentrations of Probudur were injected into the tissue surrounding the incision site, while a saline solution was used for the control group. Both doses of Probudur demonstrated a reduction in incision-induced pain behaviors.
“While the data from these studies will be further analyzed, these positive results are consistent with what we at Virpax have previously observed,” said Gerald W. Bruce, CEO of Virpax Pharmaceuticals. “We are encouraged by these initial findings and expect that the next step by the USAISR would be a full powered study comparing Probudur with free bupivacaine and EXPAREL®.”
Probudur is being developed by Virpax to significantly reduce or eliminate the need for opioids after surgery or trauma in approved indications. In pre-clinical trials, Probudur has shown long duration pain control for at least 96 hours.
“All of our RX products have CRADAs associated with them, similar to the USAISR one recently highlighted in a Forbes.com article,” Mr. Bruce added. “Virpax has developed a core competency in identifying, applying for, and winning government grants which are an essential part of our non-dilutive funding strategy. We are continuing to apply for additional grants to help fund our upcoming clinical trials.”
In addition to Probudur, Virpax is also moving forward with confirmational studies for Envelta™, with plans to file Investigational New Drug (IND) Applications in the second half of this year.
Virpax is a pharmaceutical company developing non-addictive pain management product candidates using proprietary delivery technologies. The company is initially seeking FDA approval for two prescription drug candidates, Probudur and Envelta, employing patented drug delivery platforms.
Probudur is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain, while Envelta is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer.
The company is also using its intranasal Molecular Envelope Technology (MET) to develop PES200, a product candidate for managing post-traumatic stress disorder (PTSD), and NobrXiol™, a product candidate for nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for managing rare pediatric epilepsy.
Furthering their nonprescription portfolio, Virpax is seeking approval for AnQlar, which aims to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis.
These initial positive results from the Probudur pilot study represent a significant step forward for Virpax in its mission to develop effective, non-addictive pain management solutions. With the potential to reduce the reliance on opioids in post-operative and trauma care, Probudur could bring considerable benefits to both patients and the wider healthcare sector.