Highlights:
- Both the developers of Maxigesic IV drug, AFT Pharmaceuticals and Hyloris Pharmaceuticals, will be conducting further studies on the drug’s packaging before filing for the US FDA registration.
- These studies will primarily reveal information on extractable and leachable from the packaging of Maxigesic IV, as requested by FDA in July 2022.
- Maxigesic IV is a combination of Paracetamol and Ibuprofen, used to treat post-operative pain.
Leading healthcare giant AFT Pharmaceuticals Limited (ASX:AFP) said that it will conduct further studies before filing the US Food & Drug Administration (FDA) registration for its pain relief medicine, Maxigesic IV.
Maxigesic IV is a pain relief drug that will primarily be used to treat post-operative pain. The drug consists of 1000mg paracetamol and 300mg ibuprofen solution for infusion.
Both AFT Pharmaceuticals and Hyloris Pharmaceuticals have collaborated to develop this drug. Maxigesic has secured a license in more than 100 countries across the world. The drug has also been registered in 41 countries and launched in 10 countries, including Australia, France, Germany, Indonesia and Korea.
Update on AFT Pharmaceutical’s Maxigesic IV registration by FDA:
Both the development partners of the pain relief drug, AFT and Hyloris Pharmaceuticals, are planning to initiate further studies that will provide more information to FDA related to Maxigesic IV’s packaging as per FDA’s July 2022 studies.
These studies are likely to provide further detailed information on extractable and leachable from the packaging of Maxigesic IV. The studies are expected to begin this year itself and are scheduled to get completed in the new year. Followed by the completion of the studies, AFT will be filing for the registration of Maxigesic IV.

Recent developments within AFT:
On 1 September 2022, AFT announced that it had signed up for an agreement with Massey Ventures. The agreement will allow AFT to license intellectual property (IP) to allow the development of a topical treatment for strawberry birthmarks in children.
Massey Ventures is the commercialisation arm of Massey University and the Gillies McIndoe Research Institute.
Meanwhile, the shares of AFT Pharmaceuticals were spotted trading last at AU$2.9 apiece on ASX.