Fresh off their recent distribution success of their intravenous, non-opioid based pain medication, AFT Pharmaceuticals (ASX: AFP) has ticked another box announcing the receival of regulatory approval for another form of the drug.
The oral liquid form of Maxigesic is a non-opioid based analgesic and extension of AFT’s patented Maxigesic family of medications. The oral liquid form is designed for children aged 2-12 years.
The liquid suspension has received regulatory approval in Italy and Malta, with further approvals in other countries expected.
The approval comes after a key, multi-centre study to assess clinical safety in 251 children treated for up to 11 days following the removal of their tonsils.
Managing Director of the Company, Dr. Hartley Atkinson said: “The commercialisation of the tablet version of the medicine is establishing the brand and acceptance across broad populations around the world. The new dose forms such as Oral Liquid and the intravenous form Maxigesic IV extend the addressable market and the growth potential for AFT and its global licensee partners.
“The registration of the Oral Liquid version is also a significant achievement because of the additional regulatory challenges of gaining approval for a medicine targeted at children.
“This registration now allows an upcoming launch with our partner in Italy, Angelini Pharma SpA, which is exciting as Angelini has made good progress in Italy with the tablet to date.”
The tablet and IV forms of Maxigesic are now registered in 49 and 24 countries, respectively. Regulatory approval of the new product represents further progress in commercialising the line of medications which are already licensed in more than 100 countries.
This comes at a time where the world is in serious need of non-opioid based pain management solutions. The association between postoperative opioid use and the opioid crisis is well documented as are the debilitating effects of opioid dependence and misuse. One US study found that opioid prescription had increased between 2004 and 2012 when looking at 155,000 patients undergoing low risk surgeries. Medical experts have been calling for a revised approach to postoperative pain management for years now, and AFT Pharmaceuticals is responding.
The next form of the medication that the Company is hoping to commercialise is a powdered drink sachet. The ‘Maxigesic Cold & Flu Hot Drink’ powder is already registered in Australia and licensed alongside other oral dose forms of the medication.