Mallinckrodt, NPXe Announce FDA Fast Track Designation for Inhaled Xenon Gas Therapy Trial

Mallinckrodt and NPXe announced the United States Food and Drug Administration (FDA) recently granted Fast Track designation to NPXe's Phase 3 trial of xenon gas for inhalation in Post Cardiac Arrest Patients. Fast Track designations are provided to drug candidates that "treat a serious condition and fill an unmet medical need." Xenon gas for inhalation is an investigational drug, the safety and effectiveness of which have not yet been established.

The key benefits to recipients of a Fast Track designation include more frequent contact with the FDA on the development program and the option of Rolling Review, which allows a company to submit completed sections of the New Drug Application (NDA) for individual review by the Agency. This compares with the normal process where the entire NDA must be completed before submission. The frequency of communication under the Rolling Review better assures that questions and issues are resolved quickly, potentially leading to earlier drug approval and patient access.

"Receiving Fast Track designation expedites the review process and, if approved, inhaled xenon gas will help treat patients with an unmet medical need," Bill Burns, NPXe's Chief Executive Officer, said. "It further demonstrates we are taking the appropriate steps to rapidly bring this important treatment to the market."

"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," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "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."

The companies anticipate the trial will commence in the coming months, with the first patients enrolled in the U.S.

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