OCTOBER 2021LIFE SCIENCES REVIEW8IN MY OPINIONDIGITAL THERAPY - 21ST CENTURY MEDICINE?By Daniel Schoener, Owner at Adler Innovation LLC e live in the digital era. One app tracks our sleep and wakes us up at the best time, and another one records our steps. Siri translates our verbal needs into text requests and reads us back the result. Alexa picks the right music and lighting for our homes. Information technology is about to permeate every aspect of our lives. When I learned earlier this year that the FDA had approved the first digital therapies, I was truly intrigued and somewhat mystified. Digital therapy? Is medicine becoming digital, as well?According to the definition of the trade association, DtxAlliance, Digital therapeutics delivers evidence-based therapeutic interventions to patients to prevent, manage, or treat a medical disorder or disease. Powered by high-quality software that combines medical-grade content, patient motivation, and connectivity to the healthcare system, they differentiate themselves from the vast amount of wellness apps through scientific evidence, clinical data, and regulatory approvals. To understand more, let's look at some of the key players and how their products address addiction, ADHS, and Alzheimer's.Pear Therapeutics is the furthest advanced company in the market. In the last two years, it has received two FDA approvals using an accelerated regulatory pathway and has been commercially backed by druggiant Novartis. Both products, reSET and reSET-O, target substance addiction through cognitive behavioral therapy (CBT), a method that changes thinking and behavior patterns through education and positive reinforcement. Using the apps, patients complete lessons and answer a series of quiz questions. They also report medication usage and substance cravings, triggers, and use. The more recent breakthrough product, reSET-O, is a combination therapy with buprenorphine, a drug used to treat opioid addiction, acute and chronic pain. A clinical studywith 117 opioid addicts showed increased adherence to a 12-week recovery program: with the digital therapy, 82.4% of the patients completed the entire program, only 68.4% without it. Pear Therapeutics has generated $17.5M in revenue in 2019 and has new digital treatments for schizophrenia, insomnia, and epilepsy in its pipeline.The company Lumme uses CBT to help users quit smoking. While Pear's products rely on patient self-reporting, Lumme uses machine learning to detect a cigarette craving automatically. Their app uses data from commercially available smartwatches to track the user's arm movement and detects smoking gestures with an accuracy of 95 percent. The software predicts cigarette cravings 6 min before the users feel them and sends notifications that encourage them not to smoke. Lumme's productacts on it sown as a stand-alone treatment for nicotine addiction. According to the first randomized clinical trial data Lumme reports the highest quit rates of any product in the market, with 50 percent of participants of the study being smoke-free after eight weeks. An example of a digital therapeutics company using gamification is Akili Interactive. Its most advanced product in development, AKL-T01, is a digital therapeutic designed to improve attention in children living with attention-deficit/hyperactivity disorder (ADHD). While playing what feels like a videogame, the kids receive sensory and motor stimuli that target the prefrontal cortex, a brain area affected in ADHD. In a clinical study with 348 subjects, the software significantly improved attention measures in children ages 8 to 12 with ADHD after four weeks compared to control. Akili Interactive has filed for FDA WDaniel Schoener
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