The launch of Digital Therapeutics (DTx) at Swing Therapeutics has received the FDA’s designation of Innovative Device for its smartphone-administered fibromyalgia management program.
The FDA’s Advanced Devices Program offers medical device manufacturers an accelerated regulatory review process, while offering them the ability to coordinate with the agency at all times. It intends to speed up the time it takes for new products to reach patients by maintaining the standards of other FDA authorization pathways.
Founded in 2019 and with $ 9 million in initial funding from JAZZ Venture Partners, Swing Therapeutics is developing digital therapies for people living with chronic illnesses.
His first program is aimed at fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep problems, memory loss, and mood problems, and is based on a clinically validated program that obtained an exclusive license. of the University of Manitoba.
Swing’s 12-week DTx uses acceptance and commitment therapy (ACT), forms of cognitive behavioral therapy (CBT) that help patients accept factors beyond their control and focus on making internal changes. The program includes daily learning lessons and interactive sessions that help users understand their circumstances and develop skills to manage their condition.
WHAT IS THE IMPACT?
With this designation, Swing is launching a real-world clinical trial to evaluate his DTx fibromyalgia. The company has already completed a pilot study that it says showed “a promise to improve the symptoms of people living with fibromyalgia.”
The study is called REACT-FM and is currently enrolling participants.
In addition, Swing is in the planning phase of a randomized, multicenter controlled pivot trial that is expected to be used to obtain FDA approval for its product.
“We founded Swing to meet the real unmet needs of people with chronic unattended conditions, so that they can live the best life. This mission guides us every day. We believe our engaging patient-centered digital program will significantly increase access to proven approaches that few people have been able to experience before, ”Dr. Mike Rosenbluth, founder and CEO of Swing Therapeutics, said in a statement.
“Our team is committed to creating valuable digital therapies and demonstrating solid clinical evidence to support their use. The results of our initial studies are encouraging and, with the support of the FDA, we look forward to optimizing the product as we move forward through our fundamental testing ”.
According to the National Fibromyalgia and Chronic Pain Association, an estimated 10 million people in the U.S. have fibromyalgia. Although this disease cannot be cured, several antiepileptic and antidepressant medications are used to treat it, according to the Arthritis Foundation.
In previous studies, ACT was found to be a useful and cost-effective method of treatment for fibromyalgia.
THE GREAT TREND
Virtual reality company AppliedVR is also part of the FDA’s Advanced Devices Program for its virtual reality fibromyalgia treatment tool. Named EaseVRx, the program combines VR headsets with visual and audio programs that offer CBT training, relaxation, and attention.
Other actors in the DTx space are MedRhythms, which treats neurological injuries and illnesses; Pear Therapeutics, which has addiction and insomnia programs; Better Therapeutics, which creates digital nutritional CBT therapy for diabetes; Happify Health, focused on depression and anxiety; and Akili Interactive, which has video game-based therapy for children with ADHD.