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# AFT Pharma Complete Response on Pain Killer Combo
- URL: https://www.fdaweb.com/aft-pharma-complete-response-on-pain-killer-combo/
- Published: 2022-07-01T12:00:00.000Z
- Updated: 2026-09-14T17:50:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152220

FDA has issued AFT Pharmaceuticals a complete response letter on its NDA forMaxigesic IV, a combination of 1,000 mg paracetamol and 300 mg ibuprofen solution for infusion for treating post-operative pain. According to AFT’s development partner, Hyloris Pharmaceuticals, the letter took issue with the submission’s quality section and the need to revise a risk assessment of the required leachable compound study.

Hyloris says it initially submitted a toxicological risk assessment for all leachable compounds, but it will need to “re-submit this information based on confirmed compounds quantified using validated methods. As previously stated, this request required by the FDA falls well within the parameters of our normal operational budget and can be completed expeditiously, requiring no additional clinical data to be generated.”

The company says the analgesic effect of Maxigesic IV was “demonstrated in a Phase 3 trial was supported by a range of secondary endpoints, including reduced opioid consumption compared to the paracetamol IV and ibuprofen IV treatment groups… An additional exposure study demonstrated Maxigesic IV’s efficacy and safety in an expanded population group over a longer treatment period.”