Beyond Traditional Therapeutics: How Digital Therapeutics Reshape Neurological and Neuropsychiatric Treatments
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Introduction to the Digital Therapeutics Landscape
Digital Therapeutics (DTx) is a subcategory of digital health which represents s group of technologies, products and services across healthcare and wellness industries. The global digital health in neuroscience market size was valued at USD 32.3 billion in 2023. The market is expected to grow at a compound annual growth rate (CAGR) OF 22.5% from 2024 to 2030. Ongoing digitization efforts and transformation of the healthcare sector are driving this growth.
As a result, digital therapeutics (DTx) have received significant attention from industry stakeholders, regulatory bodies, and investors. For instance, the USFDA sanctioned the Breakthrough Device Designation Program for granting approvals to digital therapeutics. As of 2022, the FDA has approved over 35 digital therapeutics and this number is expected to grow.
Prescription digital therapeutics must go through regulatory approval and have sufficient clinical data to back claims that they are suitable options for treating neurological disorders. Whereas non-prescription therapeutics don't need clinical data to enter the market.
The application of DTx in the neuroscience field deserves further exploration. Due to the complexity of the brain, traditional therapeutics are not always sufficient in treating neurological and neuropsychiatric conditions.
DTx could have a major impact on neurology and offer potential treatments for neurological diseases. Therefore, commercialisation and clinical application of digital therapeutics are growing and there is a demand for expansion to new clinical areas.
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The main advantage of digital therapeutics is that they require minimal development costs compared with pharmaceuticals (1%) and the development period is approximately half, making them an attractive option for stakeholders. Furthermore, digital therapeutics can be used at multiple points of intervention along the patient journey, such as monitoring, medication adherence, and behavioural engagement.
Case Studies
1. Treating Major Depressive Disorder with Digital Therapeutics
According to a recent press release, the FDA has cleared Otsuka Pharmaceutical's digital treatment for major depressive disorder (MDD) offering a new option for millions of people who struggle with this complex mental health condition. This is a landmark study as it’s the first prescription digital therapeutic authorized for the treatment of depression symptoms.
The treatment, Rejoyn, is a smartphone-based treatment for major depressive disorder symptoms and was jointly developed with Click Therapeutics, a digital therapeutics company. Rejoyn is intended for use alongside antidepressants.
Rejoyn is a six-week treatment program to enhance cognitive control of emotion through a combination of clinically validated cognitive emotional training exercises for the brain and short therapeutic lessons. Rejoyn is designed to target neural networks affected by depression and is hypothesized to leverage the brain's inherent neuroplasticity to alter those connections leading to symptom reduction over time.
The clearance of Rejoyn is based on data from a 3-month, multicentre, randomized, and controlled trial of 386 participants, aged 22 to 64 and diagnosed with MDD. Participants in this sample were also on antidepressant medication. In the trial, patients were randomly assigned to receive either Rejoyn or a sham control app.
Participants treated with Rejoyn showed a significant improvement in depression symptom severity. Furthermore, patients in the Rejoyn sample showed continued improvement one month after completing the treatment program.
Only 1 in 3 patients diagnosed with depression who receive antidepressants as their first-line treatment are successful. To address this, patients need access to new options like Rejoyn that capitalize on effective treatment strategies. John Kraus, Executive Vice President and Chief Medical Officer at Otsuka, emphasised this point: "While traditional approaches are often effective, many are left with only a partial response to treatment."
2. Using Digital Biomarkers to Predict Disease Progression in Parkinson's Disease
MSD has joined forces with Koneksa, a healthcare technology company developing evidence-based digital biomarkers. LEARNS is an observational study that explores the potential of digital biomarkers in evaluating and predicting disease progression in Parkinson's disease patients.
Digital biomarkers that can be assessed remotely using smartphones and wearable devices could potentially help diagnose Parkinson's and allow patients to begin treatment while still in the early stages.
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Well-validated measures of Parkinson's disease progression are essential to informing drug development. The LEARNS study aims to evaluate the reliability and responsiveness of biomarkers across time using mobile electroencephalogram (EEG), wearables, and smartphone-based assessments in neurological and sleep disorders. This technology allows researchers to measure the brain's electrical activity and identify evidence of neurological conditions such as Parkinson's disease.
The LEARNS study seeks to examine disease progression for 12 months in up to 70 people with Parkinson's disease. The clinical data collected from the LEARNS study will shape the future development of digital biomarkers of disease progression in Parkinson's disease.
Conclusion
There is an element of ambiguity and scepticism towards DTx because these devices are still in their preliminary stages, and there are still gaps in the research. For example, how and whether DTx will be evaluated against conventional therapeutics through comparative studies is yet to be explored.
Successfully applied use of DTx is dependent on strengthening real-world evidence-based validation which is what these two case studies offer. These research projects illustrate how digital therapeutics can help monitor and treat neurological and neuropsychiatric conditions. Overall, DTx have targeted neurological and psychiatric conditions with significant unmet needs that are difficult to manage with existing traditional therapeutics.
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