Hyloris Pharmaceuticals, headquartered in Belgium, announced on Wednesday that the U.S. health regulator has granted approval for their post-operative pain relief drug.
The company anticipates launching this non-opioid treatment, known as Maxigesic IV, in the United States early next year.
Maxigesic IV is an injectable medication designed for post-operative use in hospital settings or for patients who are unable to take oral medications.
This innovative drug combines paracetamol with an ibuprofen solution for infusion, offering effective pain relief and reducing inflammation without the risk of opioid addiction.
The opioid crisis in the United States has led to over half a million deaths from 1999 to 2020, making non-opioid pain management solutions a critical need.
The U.S. Food and Drug Administration (FDA) based its approval decision on data from a late-stage study, which demonstrated that Maxigesic IV was more efficient at alleviating pain compared to commonly-used intravenous paracetamol.
Hyloris CEO Stijn Van Rompay stated in an interview with Reuters that their injectable drug surpasses the competition, particularly paracetamol, which is one of the most widely used pain treatments in the United States, along with ketorolac.
Hikma Pharmaceuticals, in charge of commercializing the drug in the United States, will determine its pricing. Maxigesic IV is the result of a collaboration between Hyloris Pharmaceuticals and AFT Pharmaceuticals, a company based in New Zealand.
Following the drug’s initial sales in the United States, Hyloris expects to receive payments of up to $3.5 million linked to various milestones.
Additionally, Vertex Pharmaceuticals’ drug VX-548, which recently demonstrated promise in a mid-stage trial, may offer another non-opioid therapy option for post-operative pain management in the future.
In conclusion, the FDA’s approval of Hyloris Pharmaceuticals’ Maxigesic IV represents a significant step forward in addressing the opioid epidemic by providing a safer alternative for post-operative pain relief.
The company’s collaboration with Hikma Pharmaceuticals and potential payments tied to milestones further highlight the positive prospects for this innovative medication in the U.S. market.