Digital therapy program for fibromyalgia receives FDA breakthrough device designation

Swing Therapeutics, a digital therapeutics startup, has received an FDA breakthrough device designation for their 12 week smartphone-assisted fibromyalgia management program. This is the company's first breakthrough designation, and precedes a deluge of clinical trials scheduled for this year.

Swing Therapeutics was founded in 2019 and has raised a total of $9 million in seed funding led by JAZZ Venture partners. The company is focused on managing chronic pain, and specifically fibromyalgia.

This FDA breakthrough designation was awarded to the company's smartphone adaptation of an acceptance and commitment therapy (ACT) program originally designed and tested at the University of Manitoba. Swing Therapeutics has exclusively licensed the program, and adapted it to form their own phone-based version.

We basically used [The University of Manitoba program] as a basis for our program and then really built on top of it, and adapted it to a sort of experience that would work great for a modern day smartphone interface," says Mike Rosenbluth, the founder and CEO of Swing Therapeutics.

This FDA designation will allow Swing Therapeutics expedited review at the FDA as the company conducts a series of clinical trials on the product.

At the moment, there is no cure for fibromyalgia, but the FDA has approved three drugs that can help manage symptoms. Those include: Lyrica, which is usually prescribed to treat nerve damage, but is also used to treat fibromyalgia; Cymbalta, which was originally developed to treat depression, anxiety and diabetic neuropathy; and Savella, an SSRI that's similar to treatments for depression.

Outside of the drug world, there's some evidence ACT can help patients who live with chronic pain (including fibromyalgia).

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One meta-review of 25 studies on ACT and chronic pain, for instance, found that ACT therapy had small effects on pain intensity. But the therapeutic process of teaching patients to accept their pain (but not ignore it) was linked with moderate and long-term improvements in depression, anxiety and quality of life.

What ACT does is it tries to help people accept those symptoms and things that are uncontrollable. It helps people think about their values - what is really important to them," says Rosenbluth. And then they try to make behavior-based changes aligned with those values."

In that vein, Swing Therapeutics' platform is designed to be prescribed by a doctor as a treatment management tool. Once prescribed, the patient would enter a 41 session acceptance and commitment therapy program that's run entirely on their phone, and broken into daily doses." A daily dose" might include a prompt for a mindfulness session or a short writing prompt.

The University of Manitoba program that Swing's smartphone program is based on does have a randomized controlled trial to its name. It was initially validated in a study on 67 participants who either received treatment as usual or their regular treatment plus ACT delivered via an 8-week online course.

Completing the course was linked with improvements in depression symptoms and improvements in patients' scores on the Fibromyalgia Impact Questionnaire (FIQ-R), which measures the effects of fibromyalgia on sleep, pain perception fatigue, or psychological distress. The course appeared to help patients improve their pain acceptance" and through that mechanism the experience of fibromyalgia.

Importantly, the Swing Therapeutics program does differ slightly from the University of Manitoba program - namely, it's designed for almost daily use, over 12 weeks on a smartphone, as opposed to 8 weeks on a computer. Even these small changes warrant their own independent clinical trials to ensure this approach also helps fibromyalgia patients benefit from this specific ACT therapy program.

Swing Therapeutics has several of these clinical trials at different stages.

This spring, Swing completed enrollment of a 67-person pilot study on their adapted treatment for fibromyalgia (patients were assigned to an active control or the ACT digital therapy). This study is ongoing. Last week, Swing also launched a large-scale study called REACT-FM. This study, currently recruiting, aims to enroll about 100 to 150 patients who will use the ACT product for two weeks.

Finally, the company is also in the development phase for a Phase 3 randomized controlled trial. After completion of that study, the company plans to submit to the FDA for full approval of the platform. That study, says Rosenbluth, is planned to launch at the end of the year.

The FDA breakthrough therapy designation has already helped shape these studies. As the trials continue, this designation means the device will continue to enjoy expedited review, which could smooth the platform's journey through clinical trials.

We found it really useful to be able to have that channel dialogue with the FDA, so that we can make sure that we're aligned in clinical study design and our approaches are in line with things that the FDA expects," Rosenbluth says.

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