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Drug maker AFT Pharmaceuticals has nabbed its second approval from US drug authorities in a year to sell its Maxigesic product there.
The company this morning announced the FDA had approved AFT's application for the intravenous form of its Maxigesic IV pain relief medicine for sale within the US.
It was the second FDA approval for the company this year, after the company's rapid dissolving form of the drug was approved for sale in March - the first time a patented New Zealand developed medicine had been approved for sale in the US.
AFT co-founder and managing director Dr Hartley Atkinson said he was delighted with the decision.
"The US analgesic market is the world's largest, worth US$6.83 billion in 2023, and is forecast to grow by an estimated 4.89 percent a year until 2028," he said.
"It is a real credit to the determination, commitment, and capability of the AFT team and our research and development partner, Belgium's Hyloris Pharmaceuticals."
Atkinson said the drug was an effective alternative to opioid pain relief medicines for post-operative pain.
Chronic opioid usage in patients after surgery averaged around 9 percent and the US was grappling with a rise in drug overdoses involving opioids - which resulted in over 80,000 deaths in the US in 2021, he said.
First introduced in New Zealand in 2009 in tablet form, Maxigesic has since been licensed in more than 100 countries worldwide.
The latest approved product will go on sale either at the tail end of FY24 or early in FY25, triggering a payment of $10.1m (US $6m) to AFT from the US licensee of the medicine Hikma Pharmaceuticals.
Were the payment to be triggered this financial year, it would be in addition to AFT's current $22m-24m guidance.
AFT was entitled to 65 percent of the amount under its profit share arrangements with its development partner Hyloris Pharmaceuticals, it said.
The company also qualified for a further $4.9m (US$2.9m) reimbursement of regulatory fees paid to the FDA for the process that it expected to receive in the current financial year.