According to Medical Developments International (MVP), the FDA has lifted a clinical hold on MVP’s Penthrox methoxyflurane inhaler and, as a result, MVP is now preparing a Phase 3 trial of Penthrox for trauma pain that is expected to begin recruiting by the end of this year. The FDA issued the clinical hold letter to MVP in 2018, and MVP said in July 2019 that it expected to respond to the agency by early 2020.
Penthrox is currently available in more than 40 countries and has been approved throughout Europe for the emergency treatment of moderate to severe pain in trauma patients since 2017. In August 2020, MVP announced that it was buying the European rights back from Mundipharma.
MVP CEO Brent MacGregor commented, “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 bringing the 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 added, “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.”
Read the Medical Developments International press release.
