Addiction firm Orexo licenses app for alcohol use disorder

Swedish drugmaker Orexo, best known for its opioid addiction therapies, has licensed rights to a digital therapy that marks its first foray into the alcohol dependence category.

The deal gives Orexo US rights to Vorvida, an Internet-based app for alcohol use disorder (AUD) – based on cognitive behavioural therapy (CBT) methods – that was launched in Germany and Switzerland earlier this year by its developer Gaia AG.

Clinical trials carried out in more than 600 people with risky, problem drinking due to AUD found that those randomised to use Vorvida significantly reduced their daily alcohol consumption over three and six months compared to a control group. They also reported fewer days of binge drinking and drunkenness.

It’s not the first time that Orexa has licensed one of Gaia’s apps, which are based on an artificial intelligence platform called Broca. In August, the Swedish company also bought worldwide rights to a programme for opioid-use disorder, now codenamed OXD01, which is still in development.

OXD01 is designed to be used alongside drugs like Orexo’s Zubsolv (buprenorphine and naloxone), layering in counselling and psychosocial support on top of drug therapy to counteract the effects of opioid painkillers.

The Broca platform is used to develop apps that “engage users in highly individualised, simulated 1:1 interactions, guiding patients step-by-step towards specific goals and therapeutic targets,” says the drugmaker.

Gaia launched its first digital therapeutic in 2001 and its online depression programme Deprexis is already deployed in Germany by Servier and has been piloted in the UK.

Speaking after the OXD01 deal was announced, Orexo’s chief executive Nikolaj Sørensen said clinical trials have now clearly shown that digital therapies are able to make a difference to patients in terms of treatment outcome and compliance.

Often, counselling and support is lacking for people with opioid and other addictions, so by offering a digital therapy “we believe that we can fill a gap in the market…and make a meaningful difference for physicians who are trying to find the best solutions for their patients,” he added.

It’s easy to develop a digital therapy, but much harder to make one that is based on sound science and meets pharmaceutical therapy standards for efficacy tested using controlled clinical trials, continued Sørensen.

The regulatory climate is also much better for digital therapies, with the FDA developing standard review protocols and even priority review mechanisms. Meanwhile, in the US in particular payers are starting to create their own tools to assess them for inclusion on formularies.

With that comes an opportunity for pricing and reimbursement that allows “a business model that works for a company like Orexo,” said Sørensen, noting most of these developments have emerged in the last 12-18 months.

“We are making a commitment to the digital therapy space by building up a portfolio of products which I expect to turn into a sizeable business for Orexo in the medium term.”

Terms of the latest deal with Gaia haven’t been disclosed, but include an upfront payment, milestone payments as well as royalties, with Orexo taking responsibility for approval and commercialisation of Vorvida in the US.

AUD is a major health crisis affecting approximately 14.5 million people in the US, says Orexo, claiming more than 88,000 lives a year.