AFT update on Maxigesic IV® US registration filing

GENERAL

Fri, Sep 02 2022 08:30 am

2 September 2022
AFT update on Maxigesic IV® US registration filing
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.
For more information:
Investors Media
Dr Hartley Atkinson Richard Inder
Managing Director The Project
AFT Pharmaceuticals Tel: +64 21 645 643
Tel: +64 9488 0232

About AFT Pharmaceuticals

AFT is a growing multinational pharmaceutical company that develops, markets, and distributes a broad portfolio of pharmaceutical products across a wide range of therapeutic categories which are distributed across all major pharmaceutical distribution channels: over the counter (OTC), prescription and hospital. Our product portfolio comprises both proprietary and in-licensed products, and includes patented, branded, and generic drugs. Our business model is to develop and in-license products for sale by our own dedicated sales teams in our home markets of Australia and New Zealand and to out-license / distribute our products to local licensees and distributors to over 125 countries around the world. For more information about the company, visit our website www.aftpharm.com.