Orexo secures US rights to digital mental health therapy
Orexo has acquired the US rights to GAIA’s deprexis, a digital therapy to help patients manage symptoms of depression.
The announcement follows two earlier agreements with GAIA where Orexo acquired the exclusive US commercial rights to solutions which helps reduce risky drinking patterns in adults with alcohol use disorder and for the treatment of opioid use disorder (OUD).
The need for digital therapies due to the COVID-19 crisis is unprecedented. The COVID-19 crisis and the actions taken could result in a significant rise in mental illness. The recent emergency use authorisation policy for digital health devices for treating psychiatric disorders published by the US Food and Drug Administration (FDA) will allow Orexo to accelerate the launch of its three digital therapies in 2020.
Under the terms of the agreement, GAIA is entitled to an upfront payment and royalties will be paid based on net sales from January 1, 2022 onwards. deprexis has already been classified by the FDA and Orexo expects to launch deprexis in the US during the summer of 2020.
Nikolaj Sørensen, president and CEO at Orexo AB said: “The COVID-19 pandemic and resulting isolation and economic distress is likely to trigger a wave of mental health issues such as depression and substance abuse. With deprexis, vorvida and OXD01 Orexo can offer a range of products which could provide patients with access to quality medical devices whilst maintaining social distancing requirements. The agreement marks our third deal with GAIA and reflects our belief in the important role of digital therapeutics, which continue to generate compelling clinical data to support their use across a range of medical conditions, including depression. During this unprecedented time with COVID-19 we have seen accelerated adoption of digital therapeutics and are focused on advancing deprexis towards a launch during the summer.”
deprexis is a fully automated digital therapy developed by GAIA based on its artificial intelligence (AI) system, broca. deprexis provides the user with tailored therapeutic support by simulating effective, up-to-date and personalised cognitive behavioral therapy interventions. Its effectiveness in managing the symptoms of depression has been evaluated and published in 13 randomised clinical trials (RCTs) including more than 2,500 patients. In a 2017 study conducted by Beevers et al. in the US, the patient group utilising deprexis (n=285) were 12 times more likely to experience a +50% improvement to symptoms when compared to the control group (n=91). In this study, patients were studied for eight weeks, with 79% and 89% remaining in treatment from each group, respectively.
Dr. Mario Weiss, CEO and founder of GAIA, said: “Even before COVID-19, we believed that deprexis is almost tailor-made for the US: A proven effective, fully-automated digital depression treatment, accessible on any connected device 24/7 and available in 10 languages, including Spanish, French and Chinese. With Orexo we now have the right partner in the US to offer a digital depression treatment, with significant clinical data to support its use. Providers, payers and employers will soon be able to support the ones in need with this top-of-class solution. We are very pleased that Orexo was willing to extend our existing partnership and join us in our constant fight against the massive global burden of diseases such as depression.”