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Mayne Pharma Pushes for Stronger-for-Longer Oxycodone

Listed drug company Mayne Pharma could take Federal Court action to revive its failed push to have its longer-life generic oxycodone pain relief product introduced in Australia.

Earlier this month, Mayne Pharma lost its bid at the Administrative Appeals Tribunal to overturn the government’s decision not to register the pain drug on the Australian Register of Therapeutic Goods on safety and efficacy grounds.

The court hearing came after the government refused to register Mayne Pharma’s generic oxycodone hydrochloride sustained-release tablets in January last year.

Mayne Pharma already supplies oxycodone products in Australia, however, those drugs are effective for between four and six hours. The longer-life oxycodone product lasts for 12 hours.

Long-life oxycodone using the same formula as Mayne Pharma’s longer-life drug are available in other countries, including the widely known OxyContin brand.

Mayne Pharma applied to the AAT to present new evidence that the drug is released in two stages thus making it longer lasting. However, the Administrative Appeals Tribunal found it had no jurisdiction to hear the complaint.

It is understood the company is planning to either take Federal Court action to have the new evidence considered or to relodge at the AAT.

It comes as Mayne Pharma shakes off a horror year after a shock earnings downgrade and share price slide.

In Australia the company is increasingly focussed on specialty brands rather than its generics business.

Last month the company announced it had received TGA approval for two drugs used to treat urinary infections.

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