AFT submits Maxigesic IV® packaging data to the US FDA

AFT Pharmaceuticals (NZX.AFT, ASX.AFP) today announces it has submitted to the US

Food and Drug Administration (FDA) data the regulator requested as it considers

registration of the company’s patented intravenous pain relief medicine Maxigesic IV.

In a delay to the registration of the medicine in the US, the FDA requested in July 2022

additional data on the performance of Maxigesic IV’s primary packaging (the glass

vial in which the medicine is stored and the vial’s stopper).

AFT along with its commercialisation partner Belgium’s Hyloris Pharmaceuticals has

over the last year collated the data and submitted today.

AFT Managing Director Dr Hartley Atkinson said: “We believe the data we have

submitted will satisfy the FDA’s requirements and remove the outstanding hurdle to

registration. All going well we anticipate registration of the medicine this year and

sales to follow shortly after.”

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 is currently licensed in more than 100

countries across the globe. It has also been registered in 43 countries and launched

in 19 countries including Australia, France, Germany, and Korea. The medicine is

protected by several granted patents and pending patent applications.