Hyloris Pharmaceuticals SA announced 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.

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.

development of chronic opioid use after surgery is one of the most common post-operative complications2 with particularly devastating consequences. In the U.S., prevalence of new chronic opioid use after surgical procedures was estimated close to 6%3. In the past 2 decades, prescription opioid usage in the U.S. contributed to over 600,000 deaths related to opioid overdoses, with the annual death toll rising tenfold between 1999 and 2021 (80,000 deaths in 2021). Nearly 17,000 deaths involved prescription opioids in 20214.Patients requiring medical attention related to opioid abuse account for around $11 billion of added costs to the U.S. healthcare system annually, or 1% of all hospital costs5.