On Wednesday, Belgium-based Hyloris Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved its drug for post-operative pain, adding the drug is expected to hit the market in the United States early next year.

Branded as Maxigesic IV, the injectable pain medication was approved for use post-operatively, or when patients cannot take pain medication orally.

The drug is a combination of paracetamol and ibuprofen, formulated for infusion.  It is claimed to reduce pain and inflammation while not offering the risk of addiction, such as is seen with opioids, which have killed more than half a million Americans in the US between 1999 and 2020.

The decision by the US FDA was made using data from a late-stage study which showed the drug was more effective in relieving pain than paracetamol, a commonly used intravenous painkiller.

In an interview with Reuters, CEO Stijn Van Rompay said that the company’s injectable drug is significantly superior to the most used pain treatment in the US, patacetamol, and another commonly used pain medication, ketorolac.

According to a message to Reuters the pricing of the drug is to be determined by Hikma Pharmaceuticals, which has been given the rights to commercialize the drug in the United States.

The drug, Maxigesic IV, was developed as part of a partnership between Hyloris Pharmaceuticals and New Zealand-based AFT Pharmaceuticals.

Hyloris said that following the first US sales, it will receive a payment of as much as $3.5 million, based on milestones, among other factors.

Meanwhile Vertex Pharmaceuticals’ new painkiller, VX-548, has recently passed its mid-stage trial, and may prove the be another post-operative non-opioid therapy which will ultimately make it to the market.