Once-banned Australian pain drug to be relaunched overseas
MAY 11, 2015
An Australian-made version of a pain drug once banned in the US because of toxicity concerns is to be relaunched overseas after approval by European health regulators.
Medical Developments International has invested $10 million developing its inhalable drug and is looking forward to sales soaring, with the market for emergency pain relief in Britain and Europe worth up to $200m a year.
The company has also won the backing of the CSIRO, which invested $750,000 to help bring down the cost of manufacturing, so it can better compete with commonly used opioids, such as fentanyl and morphine.
The Penthrox inhaler administers the drug methoxyflurane for short-term pain relief. It was first used as an anaesthetic, but this was stopped in the late 70s for causing liver and kidney damage.
In 2005, the US Food and Drug Administration withdrew methoxyflurane from the market.
Medical Developments chief executive John Sharman said Penthrox, developed in the 70s by the late Melbourne anaesthetist David Komesaroff, contains just 5 per cent of the active agent of an anaesthetic and had proven to be safe and effective in clinical trials.
In Australia, the drug has been used widely as an analgesic since the 70s by hospitals, surf lifesavers, paramedics, the defence force and sports groups, including the AFL, and pulled in sales of $5.4m last year. Mr Sharman said the inhaler had many advantages over opioid, or narcotic, drugs. “You don’t die from it, you don’t get addicted and you don’t get that cumulative effect,” he said.
“And it has outstanding analgesic properties. In the UK, when the trial was under way, I saw a 16-year-old come in after a skateboarding accident with a compound fracture of the leg and not long after he took the drug he wanted to get up and walk on it.”
Mr Sharman said high production costs had previously been an issue but the company had worked closely with the CSIRO and was now operating to “world’s best practice” for hi-tech manufacturing out of its plant at Springvale in Melbourne.
This week’s Medicine and Healthcare Products Regulatory Agency approval gives the firm access to Britain, Ireland, France and Belgium, where hospital emergency departments provide a $100m market opportunity.
The company is also seeking approval for the rest of Europe, worth a further $90m a year, and is preparing a submission to the US Food & Drug Administration.
While Australia is renowned for its research and development, only a handful of local inventions have grown into globally competitive businesses in the vein of Cochlear, which developed the bionic ear, and ResMed, a leading respiratory device maker.
Industry analyst Brent Mitchell Australian firms faced a significant challenge to entering the market: “It’s the scale that is required to get into the market in terms of distribution, especially for a company with a small product portfolio. It’s very hard.”