Maxigesic IV, which is a combination of 1000mg paracetamol and 300mg ibuprofen solution, is given intravenously to adults for relieving mild to severe pain.
It received approval for the management of moderate to severe pain as an adjunct to opioid analgesics in adult people.
The NDA approval is based on positive results from a placebo-controlled, double-blind, randomised Phase III study that enrolled 276 patients who had undergone bunion surgery.
Maxigesic IV was well tolerated and provided faster onset of action and higher pain relief against Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, and placebo.
The study also demonstrated superior analgesic effect of Maxigesic IV, supported by secondary endpoints including lower opioid usage rates.
Earlier, Hyloris’ partner AFT Pharmaceuticals and Hikma Pharmaceuticals signed an exclusive license and distribution agreement for Maxigesic IV.
Distribution of Maxigesic IV in US hospitals is anticipated to begin early next year.
Following first US sales, Hyloris will receive a milestone payment of $2.1m and $1.5m relating to existing trade receivables.
Hyloris will also receive a share on any product-related revenues such as royalties, license fees, and milestone payments from AFT.
Hyloris Pharmaceuticals CEO Stijn Van Rompay said: “Bringing innovation by reformulating existing medicines highlights how Hyloris can improve patient outcomes, specifically by addressing the devastating opioid crisis in the biggest health care market in the world.
“Maxigesic IV demonstrates the potential of our strategy of bringing product candidates to market within our strict criteria: a development of seven years or less, and R&D costs averaging less than €7m.”