The US Food and Drug Administration (FDA) has approved Hyloris Pharmaceuticals’ non-opioid, intravenous painkiller, Maxigesic IV, under the trade name Combogesic IV.

The drug will be used to provide relief of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics in adults.

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Maxigesic is a combined 1,000mg paracetamol and 300mg ibuprofen solution for infusion for post-operative use. The agency approved the company’s new drug application based on positive data from a Phase III program (NCT04005755). The study results demonstrated that Hyloris’s drug significantly improved pain relief compared to paracetamol and ibuprofen alone.

Following the approval announcement, the volume of Hyloris stocks being traded multiplied almost 20 times from 17 October, when the news was released to 18 October.

In 2021, the Belgium-headquartered company joined a licensing agreement with AFT Pharmaceuticals for Maxigesic IV in eight European countries. As per the press release, Under the agreement, Hyloris “could receive a share of product-related revenues, including royalties, and milestone payments, that AFT Pharmaceuticals” earns.

Maxigesic IV will be distributed in US hospitals in early 2024. After the first sales in the region, Hyloris will be entitled to receive a milestone payment of $2.1m. Also, the company may receive $1.5m relating to existing trade receivables.

This approval arrives as the US continues to face an opioid epidemic. The US National Institutes of Health report that three million US citizens and 16 million individuals worldwide have opioid use disorder. The disorder describes a condition where individuals have a compulsive use of opioid drugs, even when wanting to stop or when the drug negatively affects their emotional or physical well-being. In the US, patients requiring medical attention due to opioid abuse cost the healthcare system approximately $11bn annually, making up 1% of all hospital costs.

This year, the FDA has taken several measures to help those struggling with the condition and reduce its occurrence. As part of its opioid prevention framework, the agency approved Narcan (naloxone) as the first non-prescription opioid overdose nasal spray for over-the-counter use and required opioid analgesic manufacturers to provide mail-back envelopes for drug dispensation in outpatient settings.