FDA clears first drug from UWA spinout iCeutica

The US FDA has approved the first drug created using technology developed at the University of Western Australia.

The drug, Zorvolex, is a non-steroidal anti-inflammatory drug to treat mild-to-moderate acute pain in adults.

It was developed by US-based Iroko Pharmaceuticals using proprietary SoluMatrix technology, licensed to Iroko by UWA spinout company iCeutica. Investors linked to Iroko acquired iCeutica in 2011, but the company has been operating as a standalone company. 

Zorvolex was designed using SoluMatrix Fine Particle Technology, which was originally developed by UWA researchers.

This technology creates submicron-sized particles of drugs designed to dissolve much more quickly than conventional drugs, to improve speed of action, lower dose requirements and reduce potential side-effects.

The UWA’s technology transfer arm, the Office of Industry and Innovation, provided proof-of-concept funding support in 2004 and exchanged the IP behind the technology with a shareholding in iCeutica in 2005.

iCeutica CEO and UWA graduate Matt Callahan said the company had now been able to take Zorvolex “from an idea all the way through approval and now on to launch. It is very satisfying to carry it all the way through - you don’t get that opportunity often in life - and as an Australian biotech, it very rarely happens.”