Tech Crunch wrote that 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).