AFT gets FDA approval for pain relief medicine

Wed, 18 Oct 2023

AFT Pharmaceuticals has received approval from the US FDA to sell its intravenous pain relief medicine, Maxigesic IV, in the US.

This marks the company's second FDA approval within a year.

The medicine is expected to go on sale in late FY'24 or early FY'25, triggering a milestone payment of US$6 million to AFT from Hikma Pharmaceuticals, the US licensee of the medicine.

AFT is entitled to 65% of this payment.

Additionally, AFT qualifies for a reimbursement of US$2.9 million in regulatory fees paid to the FDA.

If the launch of Maxigesic IV occurs within the current financial year, it will be in addition to the company's current guidance of $22-24 million.

AFT's Managing Director, Dr Hartley Atkinson, expressed delight and pride in the FDA approval and highlighted the potential of the US analgesic market, which is valued at US$6.83 billion in 2023.

Maxigesic IV aims to provide an alternative to opioid pain relief medicines for post-operative pain.