Swing awarded FDA breakthrough status for fibromyalgia DTx

Swing Therapeutics announced Thursday that its digital therapeutic (DTx) for the management of fibromyalgia gained an FDA breakthrough device designation. The company, which launched in 2019 with seed funding from JAZZ Venture Partners, also said it has initiated the real-world REACT-FM study of its therapeutic device.

Swing explained that the DTx is based on a clinically validated online therapy programme that it exclusively licensed from the University of Manitoba. The company's self-guided programme, which lasts 12 weeks and includes a maintenance mode for extended use, digitally delivers "acceptance and commitment" therapy, a form of cognitive behavioural therapy. Swing noted that its "simple-to-use" DTx includes "engaging lessons and interactive exercises," helping patients apply "well-established principles to their unique circumstances and gradually develop the ability to manage their condition." The programme also features a tool to help users triage symptom flares.

Swing has completed a pilot study of the DTx, which it said showed "promise" for improving fibromyalgia symptoms, and is also planning a randomised controlled pivotal trial to support FDA clearance. According to CEO Mike Rosenbluth, results from the company's initial studies are "encouraging," and with the support of the FDA, "we look forward to optimising the product as we advance through our pivotal trial."

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