27 August 2018 - - The United States Food and Drug Administration recently granted Fast Track designation to NPXe's Phase 3 trial of xenon gas for inhalation in Post Cardiac Arrest Patients, UK-based specialty pharmaceutical company Mallinckrodt plc (NYSE : MNK) and NPXe Ltd. said.

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 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.

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

Xenon is a noble gas that has been used as an inhaled therapy in several studies to date. In PCAS, more N-methyl-D-aspartate receptors are activated, causing extreme ion imbalances, neuronal damage and cell death.

Studies have shown that xenon may help to inhibit the NMDAR through a unique inhibition at the glycine-binding site and can help moderate the flow of damaging ions through the calcium channel.

By mitigating neuronal damage and cell death, xenon may be able to improve functional outcomes and reduce mortality rates in survivors. The FDA has not yet established the safety and effectiveness of xenon gas for inhalation for PCAS.

NPXe is developing xenon gas for inhalation for the treatment of Post-Cardiac Arrest Syndrome.

The company has a Special Protocol Agreement with the FDA and A Scientific Working Party Agreement with the European Medicines Agency.

Both the FDA and EMA have provided the sought PCAS indication with Orphan Drug status.

Orphan status prolongs the period of market exclusivity post approval. Mallinckrodt has licensed the rights to market xenon gas for inhalation in North America, Australia and Japan upon approval in each country.

The rights to market xenon gas for inhalation in the EU, United Kingdom, Norway, Switzerland and Iceland are licensed to a third party.

Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies.

Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products.