AFT update on Maxigesic IV® US registration filing

Friday 2nd September 2022

AFT Pharmaceuticals (NZX: AFT , ASX: AFP) today updates investors on its programme to obtain US Food and Drug Administration (FDA) registration of Maxigesic IV, the intravenous form of its patented pain relief medicine.

Alongside its Maxigesic IV development partner Hyloris Pharmaceuticals, AFT is planning to commence additional studies to answer the FDA’s July 2022 request for further information on Maxigesic IV’s packaging.

The studies – to provide further data on extractables and leachables from the packaging – are expected to commence before the end of this year and are due to complete in the new year. AFT will then file with the FDA once the studies are complete.

AFT Managing Director Dr Hartley Atkinson said: “AFT and Hyloris are focussed on Maxigesic IV fulfilling the significant commercial potential we see for the medicine in the world’s largest pharmaceutical market. We are looking forward to giving the FDA the requested additional data.”

Maxigesic IV, is a novel, unique combination of 1000mg paracetamol and 300mg ibuprofen solution for infusion, for the treatment of post-operative pain. It has been developed in collaboration with Hyloris and currently licensed in more than 100 countries across the globe. It has also been registered in 41 countries and launched in 10 countries including Australia, France, Germany, Indonesia and Korea. The medicine is protected by a number of granted patents and pending patent applications which extend until 2035-2038.

For and on behalf of AFT Pharmaceuticals Limited by Malcolm Tubby, Chief Financial Officer.

AFT update on Maxigesic IV® US registration filing

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