ABSTRACT
Limitations of pharmaceutical drugs and biologics for chronic diseases (e.g., medication non-adherence, adverse effects, toxicity, or inadequate efficacy) can be mitigated by mobile medical apps, known as digital therapeutics (DTx). Authorization of adjunct DTx by the US Food and Drug Administration and draft guidelines on "prescription drug use-related software" illustrate opportunities to create drug + digital combination therapies, ultimately leading towards drug-device combination products (DTx has a status of medical devices). Digital interventions (mobile, web-based, virtual reality, and video game applications) demonstrate clinically meaningful benefits for people living with Alzheimer's disease, dementia, rheumatoid arthritis, cancer, chronic pain, epilepsy, depression, and anxiety. In the respective animal disease models, preclinical studies on environmental enrichment and other non-pharmacological modalities (physical activity, social interactions, learning, and music) as surrogates for DTx "active ingredients" also show improved outcomes. In this narrative review, we discuss how drug + digital combination therapies can impact translational research, drug discovery and development, generic drug repurposing, and gene therapies. Market-driven incentives to create drug-device combination products are illustrated by Humira® (adalimumab) facing a "patent-cliff" competition with cheaper and more effective biosimilars seamlessly integrated with DTx. In conclusion, pharma and biotech companies, patients, and healthcare professionals will benefit from accelerating integration of digital interventions with pharmacotherapies.
ABSTRACT
Digital therapeutics (DTx, mobile medical apps, software as a medical device) are rapidly emerging as clinically effective treatments for diverse chronic diseases. For example, the Food and Drug Administration (FDA) has recently authorized a prescription virtual reality (VR) app for treatment of moderate to severe low back pain. The FDA has also approved an adjunct digital therapy in conjunction with buprenorphine for opioid use disorder, further illustrating opportunities to integrate digital therapeutics with pharmacotherapies. There are ongoing needs to disseminate knowledge about advances in digital interventions among health care professionals, policymakers, and the public at large. This mini-review summarizes accumulating clinical evidence of digital interventions delivered via virtual reality and mobile apps to improve opioid-based analgesia. We identified relevant randomized controlled trials (RCTs) using Embase and PubMed databases which reported pain scores with a validated pain scale (e.g., visual analog scales, graphic rating scale, numeric rating scale) and use of a digital intervention in conjunction with opiates. Among identified RCTs, the majority of studies reported improved pain scores in the digital intervention group, as compared to "treatment as usual" group. Our work suggests that VR and mobile apps can be used as adjunct digital therapies for pain management. We discuss these findings in the context of how digital health technologies can transform patient-centered pharmacy care.
