Orexo eyes real-world testing of its modia opioid use disorder app

Orexo will start a new study of its modia app – used to treat people with opioid use disorder – to test how it performs in real-world settings.

The Swedish drugmaker has teamed up with consultancy ApexB.io and pharmacy group Magellan Rx Management on the study of the digital therapeutic, which provides tailored cognitive behavioural therapy (CBT) via a mobile device or PC.

The modia app is designed to be used alongside drug therapy used to tackle the dependency experienced by people with OUD. Orexo is a supplier of buprenorphine-based OUD therapies, including its flagship Zubsolv brand which accounts for the bulk of its revenues.

While it’s well recognised that drug therapy needs to be coupled with counselling to help people with OUD kick the habit effectively, a recent study found that only 36% of healthcare providers in the US said there was an adequate number of counsellors in their area.

modia has already had a limited launch in the US under legislation that has made it possible to secure reimbursement for certain digital products for psychiatric disorders during the COVID-19 pandemic, with a broader rollout now due to take place in the latter half of this year once additional technical and clinical testing has taken place.

In November, a report from the influential Institute for Clinical and Economic Review (ICER) in the US concluded that there isn’t enough evidence yet to suggest that digital therapies for people with OUD can improve on standard interventions – although modia wasn’t included in that assessment.

The real-world studies “will provide further data behind the need for an easily accessible digital treatment option for OUD,” said Orexo in a statement.

Despite a clampdown by the authorities, there are tens of thousands of overdose-related deaths in the US every year, many of which are due to opioids.

Levels rose 21% to 83,000 in the 12 months to June 2020, according to figures from the Centres for Disease Control and Prevention (CDC) in the US, an all-time high that has been linked to mental health issues exacerbated by the COVID-19 pandemic.

“The agreement with a group of leading payers to collect real world evidence from patients using modia in combination with a buprenorphine product is a testimony to the genuine interest that exist to make new treatment tools available,” said Orexo’s chief executive Nikolaj Sørensen.

“Proving the clinical value of modia is critical to ensure patients get the help and recovery they need, and to unleash [its] full commercial potential,” he added.

Last year, Orexo launched two other digital therapies – Vorvida for alcohol misuse and Deprexis for depression – which like modia are licensed from German digital health specialist GAIA.

It has previously said each has the potential to make between $120 million and $225 million in US net sales, if reimbursement pathways can be teased out.