Orexo recently launched the digital therapies deprexis and vorvida in the US. Lu Rahman talked to Nikolaj Sørensen, President and CEO about these therapies and the company’s expertise
LR: Explain how digital therapies work and the type of conditions they are most suited to treat.
NS: Digital therapeutics are evidence-based therapeutic interventions driven by high-quality software programmes that can be used as stand-alone therapies or in conjunction with other treatments, such as pharmaceuticals or in person therapy, to prevent, manage or treat patients with a broad spectrum of mental, physical and behavioural conditions.
Digital therapeutics are particularly valuable in the substance abuse and mental health space where patients require steady support. For instance, patients suffering from opioid use disorder in the US are still experiencing limited access to qualified counselling and psychological support due to a lack of qualified therapists to provide medication assisted therapy. This support is critical, especially during the beginning of treatment, a highly crucial time in patients’ recovery process. Digital therapeutics can address this gap by providing fully automated and necessary individualised support 24/7, alongside traditional medication treatments. Digital therapeutics could also play an important role in providing treatment for patients at a time where COVID-19 has impacted access to treatment.
LR: In terms of deprexis and vorvida, how do they compare with more traditional therapeutics and what would you say the advantages of digital therapies can be?
NS: Traditional therapeutics for depression, alcohol misuse, and mental health disorders have generally been centred around a counselling programme with scheduled face-to-face therapy and pharmacological treatments. The key advantage of digital therapeutics is real-time, immediate access to treatment for patients, without the need to schedule face-to-face appointments. In addition to increased support, these therapies can also help patients on a waiting list or similar before engaging with a qualified counsellor.
LR: Describe the process post development – what is the approval process like and what does the clinical trial process look like?
NS: The COVID-19 pandemic prompted the US Food and Drug Administration to introduce an emergency policy for digital therapeutics to increase access to digital health therapeutic devices for psychiatric disorders. As such, Orexo decided to accelerate its digital therapeutics strategy and launched both deprexis and vorvida in July.
The effectiveness of deprexis in managing the symptoms of depression has already 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 7 % and 89% remaining in treatment from each group, respectively.
vorvida is scientifically proven to reduce troublesome drinking patterns in adults with harmful alcohol consumption. In a randomised controlled trial, conducted in Germany, involving 608 adults with problematic alcohol intake, researchers found that participants in the intervention group using vorvida, saw a significant reduction in their daily alcohol consumption over three and six months, with significant effect sizes. Additionally, in comparison to the control group, vorvida users reported fewer days of binge drinking and drunkenness while stating high acceptance and utility rates of vorvida at the same time.
LR: How do you see the market for these therapies expanding and where are the opportunities for therapy developers? Are there any particular areas of unmet need?
NS: The market for digital therapeutics has grown thanks to advances in technology and data capability alongside real-world outcomes that reflect patient satisfaction outcomes. The potential application of digital therapeutics is enormous. Digital therapeutics have allowed developers to pursue innovative treatments, pushing beyond traditional treatments and empowering patients with individualised support.
The most developed market with the clearest impact is in diabetes, especially type 2, but other areas such as addiction and mental health are areas where there is a clear unmet need. Seeing the strong synergies between digital therapeutics and Orexo’s pharmaceutical pipeline, we acquired the rights to three digital therapeutics in the last year. All three provide access to treatment in areas of unmet need – substance misuse, and mental health, and where we believe digital therapies have great potential – opioid use disorder (OXD01), alcohol misuse (vorvida) and symptoms of depression (deprexis).
Nikolaj Sørensen, President and CEO of Orexo has held senior management positions at Pfizer with a focus on commercialisation in Europe, and Chairman of the Board and Managing Director at Pfizer AB. Prior to Pfizer Nikolaj Sørensen served as a management consultant at Boston Consulting Group (BCG), leading several projects within M&A, commercial transformation, and turnarounds.