Digital therapeutics (DTx) startup Swing Therapeutics has been granted FDA Breakthrough Device Designation for its smartphone-administered fibromyalgia management program.

The FDA’s Breakthrough Devices Program gives medical device manufacturers an expedited regulatory review process while offering them the chance to coordinate with the agency throughout. It intends to speed up the time it takes for new products to reach patients while maintaining the standards of the FDA’s other authorization pathways.

Founded in 2019 and with $9 million in seed funding from JAZZ Venture Partners, Swing Therapeutics develops digital therapies for people living with chronic conditions.

Its first program targets fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep problems, memory loss and mood issues, and is based on a clinically validated program that it exclusively licensed from 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 outside of 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’S THE IMPACT?

With this designation, Swing is launching a real-world clinical trial to assess its fibromyalgia DTx. The company has already completed a pilot study, which it says showed “promise for improving the symptoms of people living with fibromyalgia.”

The study is called REACT-FM and is currently enrolling participants.

Additionally, Swing is in the planning stage of a multicenter, randomized controlled pivotal trial that it hopes will be used to score FDA clearance for its product.

“We founded Swing to address the real unmet needs of people with underserved chronic conditions, so they can live their best lives. This mission guides us each day. We believe that our engaging digital patient-centered program will significantly increase access to proven approaches that previously very few people have been able to experience,” Dr. Mike Rosenbluth, founder and CEO of Swing Therapeutics, said in a statement.

“Our team is committed to creating valuable digital therapies and demonstrating strong 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 advance through our pivotal trial.”

An estimated 10 million people in the U.S. have fibromyalgia, according to the National Fibromyalgia and Chronic Pain Association. While there is no cure for the condition, a number of different anti-epileptic and antidepressant medications are used to treat it, according to the Arthritis Foundation.

In previous studies, ACT was found to be a cost-effective and useful treatment method for fibromyalgia.

THE LARGER TREND

Virtual reality company AppliedVR is also part of the FDA Breakthrough Devices Program for its virtual reality fibromyalgia-treating tool. Named EaseVRx, the program combines a VR headset with visual and audio programs that deliver CBT, relaxation and mindfulness training.

Other players in the DTx space are MedRhythms, which treats neurologic injuries and diseases; Pear Therapeutics, which has programs for addiction and insomnia; Better Therapeutics, which creates nutritional CBT digital therapeutics for diabetes; Happify Health, which focuses on depression and anxiety; and Akili Interactive, which has a video game-based therapy for kids with ADHD.