The FDA has granted fast track designation to NeuroproteXeon (NPXe) and Mallinckrodt’s inhaled xenon gas for the treatment of post-cardiac arrest syndrome (PCAS), the companies said. A Phase 3 trial of inhaled xenon for that indication is expected to get underway in the next few months.
NPXe’s Xenex inhaled xenon has received orphan drug designation from the FDA and EMA. The gas is delivered in hospital settings using the company’s XDS delivery system, and a portable device for use in ambulances is in development. In 2017, Mallinckrodt acquired rights to market the product in the North America, Australia, and Japan.
NPXe CEO Bill Burns said, “Receiving fast track designation expedites the review process and, if approved, inhaled xenon gas will help treat patients with an unmet medical need. It further demonstrates we are taking the appropriate steps to rapidly bring this important treatment to the market.”
Mallinckrodt Executive VP and Chief Scientific Officer Steven Romano said, “We are pleased to see the FDA recognize the potential value xenon gas for inhalation can provide in addressing these underserved patients who have a critical need. We look forward to the upcoming start of the Phase 3 trial and learning more about this potential therapeutic option in a population of resuscitated cardiac arrest patients.”
Read the Mallinckrodt and NPXe press release.
