SYDNEY: Medical Developments International (ASX: MVP) announced that the US Food and Drug Administration (FDA) has unconditionally lifted the agency’s clinical hold on Penthrox.
This means that MVP can immediately begin preparing for its Phase III US clinical trial. As anticipated, the trial will be conducted on a targeted trauma and associated pain patient group. We expect that the 2-year trial will commence recruitment in late 2022.
CEO Brent MacGregor said: “We are thrilled with this news which allows us to move forward quickly with preparations for our clinical trial. After years of hard work, our team is buoyed by the prospect of bringingthe many benefits of Penthrox to the US market. This will strongly complement our growing Penthrox success in Europe, and fully supports our further investment in the product.”
Chair Gordon Naylor said: “This news is important as it brings Penthrox a step closer to licensure in the US market and because the FDA is seen as a global regulatory leader. Our renewed focus on the core business continues to yield results.”
MVP is an Australian company delivering emergency medical solutions dedicated to improving patient outcomes. MVP is a leader in emergency pain relief and respiratory products. www.medicaldev.com