AFT Pharmaceuticals (AFT’) today announces it has successfully registered the intravenous form of its successful Maxigesic’ pain relief medication with Australia’s Therapeutic Goods Administration (TGA).
Maxigesic IV® (paracetamol 1000 mg and ibuprofen (as sodium dihydrate) 300 mg) in 100 mL solution for infusion vial has now been placed upon the Australian Register of Therapeutic Goods (ARTG), giving AFT approval to sell this line extension of Maxigesic in Australia.
Sales of Maxigesic IV® are now expected to take place in the current financial year (FY2020). Meanwhile, the (ARTG) registration clears the way for regulatory filings in a number of other territories including but not limited to Mexico, South East Asia, Korea and the Middle East, all of which rely upon registration by key global reference regulators such as the TGA in Australia.
Maxigesic IV has been developed as a line extension to Maxigesic tablets, for post-operative pain relief in hospitals where patients cannot take an oral pain relief medicine such as Maxigesic.
A major Phase 3 clinical trial conducted in 276 patients in Texas and Maryland USA found that Maxigesic IV provided significantly better pain relief than either paracetamol (acetaminophen) IV or ibuprofen IV alone in the same doses. *
AFT Managing Director, Dr Hartley Atkinson, says he is very pleased to further extend the company’s offering of the Maxigesic portfolio.
“With a population of over 25 million** and being the largest home market for AFT, we believe that Australia represents great potential for Maxigesic IV. Meanwhile, registration with the TGA is an important first step towards the commercialisation of the medication in other markets,” said Dr Atkinson.
Dr Hartley Atkinson,
CEO, AFT Pharmaceuticals Ltd
Phone: +64 9 488 0232
Phone: +64 21 645 643
About AFT Pharmaceuticals
AFT is a growing multinational pharmaceutical company that develops, markets and distributes a broad portfolio of pharmaceutical products across a wide range of therapeutic categories which are distributed across all major pharmaceutical distribution channels: over-the-counter (OTC), prescription and hospital. Our product portfolio comprises both proprietary and in-licensed products, and includes patented, branded and generic drugs. Our business model is to develop and in-license products for sale by our own dedicated sales teams in our home markets of Australia and New Zealand and in certain Southeast Asian markets, and to out-license our products to local licensees and distributors to the rest of the world. For more information: www.aftpharm.com
* Daniels SE et al. Efficacy and safety of an IV acetaminophen/ibuprofen combination after bunionectomy. A randomized, double-blind, factorial, placebo-controlled trial. Clinical Therapeutics, in press.
** Source: https://www.worldometers.info/world-population/australia-population/