Virpax Confirms Positive Results with US Army with Probudur™ for Combat Care Study
Virpax Pharmaceuticals (NASDAQ: VRPX) has announced positive results from a comprehensive study of Probudur™ conducted by the U.S. Army Institute of Surgical Research (USAISR). The study, following an initial pilot study under a Cooperative Research and Development Agreement (CRADA), evaluated Probudur's effectiveness in reducing pain behaviors in a rat model of incisional pain.
The study compared Probudur with free bupivacaine and EXPAREL®, testing various concentrations of Probudur injected around incision sites. Results showed that Probudur doses effectively reduced incision-induced pain behaviors. In preclinical studies, Probudur demonstrated long-duration pain control lasting at least 96 hours, with rat models showing analgesia for up to five days and in vitro studies showing slow bupivacaine release for up to six days.
Virpax Pharmaceuticals (NASDAQ: VRPX) ha annunciato risultati positivi da uno studio completo su Probudur™ condotto dall'Istituto di Ricerca Chirurgica dell'Esercito degli Stati Uniti (USAISR). Lo studio, che ha seguito un primo studio pilota sotto un Accordo di Ricerca e Sviluppo Cooperativo (CRADA), ha valutato l'efficacia di Probudur nella riduzione dei comportamenti dolorosi in un modello animale di dolore incisionale.
Lo studio ha confrontato Probudur con bupivacaina libera ed EXPAREL®, testando varie concentrazioni di Probudur iniettate attorno ai siti di incisione. I risultati hanno mostrato che le dosi di Probudur riducevano efficacemente i comportamenti dolorosi indotti dall'incisione. Negli studi preclinici, Probudur ha dimostrato un controllo del dolore di lunga durata, che dura almeno 96 ore, con modelli di ratto che mostrano analgesia fino a cinque giorni e studi in vitro che mostrano un rilascio lento di bupivacaina fino a sei giorni.
Virpax Pharmaceuticals (NASDAQ: VRPX) ha anunciado resultados positivos de un estudio completo sobre Probudur™ realizado por el Instituto de Investigación Quirúrgica del Ejército de EE. UU. (USAISR). El estudio, que siguió a un estudio piloto inicial bajo un Acuerdo de Investigación y Desarrollo Cooperativo (CRADA), evaluó la efectividad de Probudur en la reducción de comportamientos de dolor en un modelo de rata de dolor por incisión.
El estudio comparó Probudur con bupivacaína libre y EXPAREL®, probando varias concentraciones de Probudur inyectadas alrededor de los sitios de incisión. Los resultados mostraron que las dosis de Probudur redujeron efectivamente los comportamientos de dolor inducidos por la incisión. En estudios preclínicos, Probudur demostró un control del dolor de larga duración que dura al menos 96 horas, con modelos de ratas que mostraron analgesia durante hasta cinco días y estudios in vitro que muestran una liberación lenta de bupivacaína durante hasta seis días.
Virpax Pharmaceuticals (NASDAQ: VRPX)는 미국 육군 외과 연구소(USAISR)에서 수행한 Probudur™에 대한 포괄적인 연구에서 긍정적인 결과를 발표했습니다. 이 연구는 협력 연구 및 개발 협정(CRADA) 하에 초기 파일럿 연구에 이어 진행되었으며, Probudur의 절개 통증 모델에서 통증 행동 감소 효과를 평가했습니다.
연구는 Probudur를 자유형 부피바카인 및 EXPAREL®과 비교하고 절개 부위 주변에 주입된 다양한 농도의 Probudur를 테스트했습니다. 결과는 Probudur 용량이 절개로 유도된 통증 행동을 효과적으로 감소시켰음을 보여주었습니다. 전임상 연구에서 Probudur는 최소 96시간 동안 지속되는 장기간 통증 조절을 보여주었으며, 쥐 모델에서는 최대 5일 동안 진통 효과를 보였고, 시험관 연구에서는 최대 6일 동안 느린 부피바카인 방출을 보여주었습니다.
Virpax Pharmaceuticals (NASDAQ: VRPX) a annoncé des résultats positifs d'une étude complète sur Probudur™ réalisée par l'Institut de recherche chirurgicale de l'armée américaine (USAISR). L'étude, qui a suivi une étude pilote initiale dans le cadre d'un accord de recherche et développement coopératif (CRADA), a évalué l'efficacité de Probudur dans la réduction des comportements douloureux dans un modèle animal de douleur incisionnelle.
L'étude a comparé Probudur avec de la bupivacaïne libre et EXPAREL®, en testant diverses concentrations de Probudur injectées autour des sites d'incision. Les résultats ont montré que les doses de Probudur réduisaient efficacement les comportements douloureux induits par l'incision. Dans des études précliniques, Probudur a démontré un contrôle de la douleur de longue durée d'au moins 96 heures, avec des modèles de rats montrant une analgésie allant jusqu'à cinq jours et des études in vitro montrant une libération lente de bupivacaïne pendant jusqu'à six jours.
Virpax Pharmaceuticals (NASDAQ: VRPX) hat positive Ergebnisse aus einer umfassenden Studie zu Probudur™ bekannt gegeben, die vom U.S. Army Institute of Surgical Research (USAISR) durchgeführt wurde. Die Studie, die auf einer ersten Pilotstudie im Rahmen einer Kooperationsforschungs- und Entwicklungsvereinbarung (CRADA) basierte, bewertete die Wirksamkeit von Probudur bei der Reduzierung von Schmerzverhalten in einem Rattenmodell für Inzisionsschmerzen.
Die Studie verglich Probudur mit freier Bupivacain und EXPAREL® und testete verschiedene Konzentrationen von Probudur, die um die Inzisionsstellen injiziert wurden. Die Ergebnisse zeigten, dass Probudur-Dosen das durch die Inzision induzierte Schmerzverhalten effektiv reduzierten. In präklinischen Studien zeigte Probudur eine langanhaltende Schmerzbekämpfung von mindestens 96 Stunden, wobei Rattenmodelle eine Analgesie von bis zu fünf Tagen zeigten und In-vitro-Studien eine langsame Freisetzung von Bupivacain über bis zu sechs Tage zeigten.
- Successful completion of U.S. Army study showing positive results in pain reduction
- Preclinical data demonstrates extended pain control duration of up to 96 hours
- In vitro studies show sustained bupivacaine release for up to 6 days
- None.
Insights
The successful completion of the U.S. Army study for Probudur represents a significant milestone in the development of next-generation pain management solutions. The involvement of USAISR, the military's premier trauma research organization, adds substantial credibility to these findings and suggests potential strategic importance for both military and civilian applications.
The study's results are particularly noteworthy for three key reasons: First, Probudur's demonstrated ability to provide up to 96 hours of pain control, with some models showing efficacy up to 5-6 days, significantly exceeds current standard-of-care local anesthetics, which typically last 24-72 hours. Second, the direct comparison with EXPAREL®, a current market leader in extended-release local anesthetics, positions Probudur competitively in the $5.5 billion global local anesthetic market. Third, the potential to reduce or eliminate post-surgical opioid use addresses a critical medical need amid the ongoing opioid crisis.
The sodium channel binding mechanism provides a targeted approach to pain management, potentially offering improved safety compared to systemic treatments. This could be particularly valuable in military medicine, where rapid recovery and reduced dependency on opioids are crucial. For civilian applications, the extended duration of action could significantly improve post-surgical recovery protocols and reduce healthcare costs associated with pain management.
However, several critical factors warrant attention: First, while rat models show promising results, human trials will be necessary to confirm these findings. Second, the regulatory pathway, particularly given the military involvement, could potentially be expedited but still requires substantial clinical validation. Third, manufacturing scalability and cost-effectiveness compared to existing solutions will be important for market penetration.
The USAISR is the
Various concentrations of Probudur were injected into the tissue around the incision site as well as a saline solution for the control group. The doses of Probudur showed reduction in incision-induced pain behaviors. “These positive results are consistent with what we at Virpax have previously observed and we are encouraged by these findings,” commented Jatinder Dhaliwal, Chief Executive Officer of Virpax.
Probudur is being developed to achieve the overall goal of safe and effective pain control during the perioperative period and to significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channels, preventing pain signals from reaching the brain. In preclinical studies, Probudur has shown long duration pain control for at least 96 hours, with a rat incisional model demonstrating analgesia for up to five days and in vitro studies demonstrating a slow release of bupivacaine that lasted for up to six (6) days.
About Virpax Pharmaceuticals, Inc.
Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking the
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FAQ
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