Hyloris Pharmaceuticals SA announced that Maxigesic® IV has been approved for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary.
The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo. The superior analgesic effect of Maxigesic® IV was also supported by a range of secondary endpoints, including reduced opioid usage rates.
Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “I’m exceptionally proud of what the team at Hyloris achieved, together with our development partner AFT Pharmaceuticals.”
“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 7 years or less, and R&D costs averaging less than EUR 7 million.1”
An exclusive license and distribution agreement for the U.S., was already signed between Hyloris’ partner AFT Pharmaceuticals (“AFT”) and Hikma Pharmaceuticals (“Hikma”). Under the terms of the development collaboration agreement between Hyloris and AFT, Hyloris is eligible to receive a share on any product-related revenues, such as license fees, royalties and milestone payments, received by AFT.
Distribution of Maxigesic® IV in U.S. hospitals should start in early 2024. Following first U.S. sales, Hyloris will be entitled to a milestone payment of USD 2,1 million. In addition, the payment of USD 1,5 million (approximately EUR 1,4 million) relating to existing trade receivables is expected.
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