Maxigesic’s tagline goes: Put it to the test for your pain. Its maker—pharma company AFT Pharmaceuticals (ASX: AFP) —did indeed put the med to the test, and it came out as a winner, bagging FDA’s approval.

Sort of like a super tablet, Maxigesic combines the powers of ibuprofen and paracetamol to create a super powerful pain relief solution. The US Food and Drug Administration has approved a rapid-release tablet form of Maxigesic for the management of mild to moderate acute pain in the US.  

AFT Managing Director Dr Hartley Atkinson shared, “We are delighted with the FDA approval of this prescription medicine and excited about the growth opportunities it opens for the company. We have held talks with potential US licensees for the medicine and are evaluating US market entry plans to maximise its commercial potential. We also importantly see this as a therapeutic option to help doctors battle the opioid epidemic in the US.” 

Maxigesic Rapid is a unique, patented combination of 325 mg of paracetamol and 97.5 mg of ibuprofen that deploys a patented rapid-release technology. With this approval, the Company gains access to an analgesic market in the US worth over $10 billion and is expected to grow by 5.8% a year between now and 2027.   

According to Atkinson, the FDA approval represents the first step for the family of medicines in the important US market. The company is awaiting approval for the intravenous form of the patented medicine Maxigesic IV (the FDA has asked for more details) and is also considering the release of other dose forms in the market.  

He added, “The Maxigesic commercialisation programme continues to make steady progress and the increasing regulatory approvals and consequent launches will contribute to our international sales going forward.”     

Maxigesic has achieved further commercial success along with its recent approval in the US. The Maxigesic Oral Liquid, which contains a distinctive combination of 160 mg paracetamol and 48 mg ibuprofen per 5 ml oral suspension, has also been approved in an additional 12 European countries through the decentralized registration procedure of the European Union. This patented formula is specifically designed for children.

It also clears the way for registration approvals of the medicine in Estonia, Hungary, Lithuania, Latvia, Slovenia, Bulgaria, Cyprus, the Czech Republic, Romania, Slovakia, Greece and Poland.  

Besides providing pain relief solutions, the Company is also working on developing antibiotic eye drops to address eye infections. It will spend about $12 million a year on this project. 

In H1 FY23, AFT’s profit fell over 60% as revenue picked up 18%. The revenue increase was thanks to its many new launches, given that AFT launched 11 new products in Australasia, and plans on launching about 15 new in the second half. However, slow product rollouts, withdrawal from Russia amid ongoing tensions and reduced licensing income stymied its profits. 

The FDA approval comes as a sigh of relief, possibly setting AFT back on the path to profitability. For the medicine’s IV iterations, however, FDA’s jury is still out and demands more time. Till then, its other products are likely to see it through.