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EU approves opioid treatment, amid fears of US-like crisis

Published on 22/11/17 at 09:35am

The EMA has given approval for the treatment of Orexo’s Zubsolv, a therapy for the treatment of opioid dependence. The medicine has gained approval as a rapidly-disintegrating treatment option for those struggling with addiction to opioids.

The fact that the treatment disintegrates means that the treatment is much more difficult to abuse, as it can be taken within a supervised environment and therefore adherence to the therapy can be better observed.

Zubsolv is a tablet that is taken sublingually and is to be used within a wider support framework of medical, social and psychological treatment. It will be made available in six different strengths for use across Europe.

The press release states that the therapy: “offers the potential for finer titration and individualized dosing with potentially fewer tablets compared with existing opioid dependence medicines”.

Nikolaj Sørensen, President and CEO at Orexo AB, said: “Our ambition is to make Zubsolv available to patients outside the US, and this approval is an important step in realizing this goal. We look forward to continuing our journey with Mundipharma, our partner, reaching out with this unique product globally and introducing an important new option in the care of those suffering from opioid dependence.”

The EMA’s decision to offer wider treatment choices for patients suffering from opioid dependence comes amid a fear that the opioid epidemic seen across the US could spread to the EU. Though the opioid epidemic was stoked by the proliferation and easy-access to opioid painkillers in the US, it was exacerbated when there was a subsequent crackdown on access to such drugs.

This led to users to turn to alternatives, resulting in the rising use of heroin and, within that, the higher rates of cutting heroin with fentanyl – an extremely potent synthetic opioid that has led to a number of overdoses.

There is now a growing associated of deaths through the use of fentanyl in Europe, with overdose deaths rising for a third consecutive year in 2015, 81% being related to opioids. This approval then represents a means of fighting back against this growing trend.

Ben Hargreaves

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