Hyloris Pharma receives US-FDA approval for Maxigesic IV for mild to moderate pain

Hyloris Pharmaceuticals SA, a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, announces 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 programme 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.”

An exclusive license and distribution agreement for the US, 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 US hospitals should start in early 2024. Following first US 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.

The development of chronic opioid use after surgery is one of the most common post-operative complications with particularly devastating consequences. In the US, prevalence of new chronic opioid use after surgical procedures was estimated close to 6%.

In the past 2 decades, prescription opioid usage in the US 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 2021.

Patients requiring medical attention related to opioid abuse account for around $11 billion of added costs to the US healthcare system annually, or 1% of all hospital costs.

Post-operative pain is a normal response to surgical intervention and is a cause of delayed recovery and discharge after surgery.

The global post-operative pain therapeutics market reached a value of USD 12.6 billion in 2023 and is anticipated to grow at a CAGR of 4.7% to reach a value of USD 19 billion by 2032, with the US as the largest market.

Approximately 50 million surgeries are performed in the US annually. Pain relief after surgery continues to be a major medical challenge with more than 80% of patients reporting acute post-operative pain. Medical professionals are increasingly aware of the societal impact of opioid abuse, as evidenced by the decrease in opioid prescriptions over the last decade in the US, adding to the need for potent non-opioid alternatives.

Maxigesic IV is a unique combination of 1000mg paracetamol with 300mg ibuprofen solution for infusion for use post-operatively. Results from a randomised, double-blind, placebo-controlled phase 3 trial in 276 patients following bunion surgery demonstrated that Maxigesic IV was well-tolerated and had a faster onset of action and offered higher pain relief compared to Ibuprofen IV or paracetamol IV alone in the same doses.

Moreover, the superior analgesic effect of Maxigesic IV was supported by a range of secondary endpoints, including reduced opioid consumption compared to the paracetamol IV and ibuprofen IV treatment groups (p-value < 0.005)10. Hyloris holds several patents for the US market, with the latest expiring in 2038.

Maxigesic IV is, to date, licensed in over 100 countries, approved in over 40 countries and marketed in over 20 countries.

Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors.

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