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Virpax Announces Positive Results of Swine Model Pilot Study for Probudur™
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Disclaimer: The following article is intended for informational purposes only and should not be construed as professional medical advice. Always seek the guidance of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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Virpax® Pharmaceuticals, Inc. (NASDAQ: VRPX), a company dedicated to developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders, and anti-viral barrier indications, has recently announced promising results from a Swine Model pilot study for Probudur™, its long-acting liposomal bupivacaine formulation. This formulation aims to provide both immediate and extended pain relief when injected at a wound site.
Pharmacokinetics and Safety Findings
The pilot study conducted by Virpax aimed to evaluate the pharmacokinetics (PK) and safety profile of Probudur in a swine model. This was done to determine how the drug is absorbed, distributed, metabolized, and excreted in the body, as well as to identify any potential adverse effects. The study involved subcutaneous injection of Probudur into four juvenile domestic pigs at a dose of 30 mg/kg. The results were highly encouraging. Probudur demonstrated a long-term, slow-release profile and was well-tolerated by all pigs involved in the study. Histopathology conducted at the injection sites showed no adverse reactions, indicating the safety of the formulation.
Gerald Bruce, CEO of Virpax Pharmaceuticals, commented on the findings: "Our study results to date for Probudur, as expected, have consistently been positive and support our belief that Probudur has the potential to provide both immediate relief as well as sustained relief at the wound site." Probudur is being developed with the goal of reducing or even eliminating the need for opioids after surgery in approved indications. This local anesthetic works by binding to sodium channels, which prevents pain signals from reaching the brain. Pre-clinical studies have shown Probudur can offer long-duration pain control for at least 96 hours. Specifically, a rat incisional model demonstrated analgesia for up to five days, and in vitro studies showed a slow release of bupivacaine lasting up to six days.
With the promising results from the pilot study, Virpax is set to continue its development efforts for Probudur. The company has an agreement to negotiate additional funding from a new institutional investor. This funding will facilitate the completion of remaining necessary studies. Virpax aims to file its Investigational New Drug Application (IND) for Probudur by the end of the year.
About Virpax Pharmaceuticals
Virpax Pharmaceuticals is focused on developing branded, non-addictive pain management product candidates using proprietary technologies to optimize and target drug delivery. The company is seeking FDA approval for two prescription drug candidates employing different patented drug delivery platforms:
Probudur™: A single injection liposomal bupivacaine formulation developed to manage post-operative pain.
Envelta™: An intranasal molecular envelope enkephalin formulation developed to manage acute and chronic pain, including cancer-associated pain.
Additionally, Virpax is utilizing its intranasal Molecular Envelope Technology (MET) to develop:
NobrXiol™: A prescription product candidate for the nasal delivery of pharmaceutical-grade cannabidiol (CBD) for managing rare pediatric epilepsy.
Virpax has established competitive cooperative research and development agreements (CRADAs) for two of its prescription drug candidates, one with the National Institutes of Health (NIH) and one with the Department of Defense (DOD).
The company is also pursuing approval for two nonprescription product candidates:
AnQlar™: Developed to inhibit viral replication caused by influenza or SARS-CoV-2.
Epoladerm™: A topical diclofenac spray film formulation developed to manage pain associated with osteoarthritis.
The study's success supports the potential of Probudur to provide both immediate and sustained pain relief, thus paving the way for the reduction or elimination of opioid use post-surgery. With further studies and additional funding, Virpax aims to advance toward regulatory approval, continuing its mission to develop innovative, non-addictive pain management solutions.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always seek the guidance of your physician or other qualified health provider with any questions you may have regarding a medical condition.
Real-time information is available daily at https://stockregion.net