Swing Therapeutics receives FDA authorisation for digital therapeutic for fibromyalgia
Betsy Goodfellow | May 22, 2023 | News story | Medical Communications | CBT, Devices, FDA, Swing Therapeutics, fibromyalgia
Swing Therapeutics has announced that it has received De Novo marketing authorisation from the US Food and Drug Administration for Stanza, its prescription digital therapeutic for the treatment of fibromyalgia symptoms.
Affecting over 10 million Americans, fibromyalgia is a chronic pain condition that can be life-changing and debilitating. Many approved medications have only moderate efficacy and along with various side effects. Current standard-of-care often comprises cognitive behavioural therapy (CBT), acceptance and commitment therapy (ACT), as well as prescribed drugs and exercise, all which patients pursue largely without clinical support.
However, Stanza is a smartphone-based prescription digital therapeutic (PDT), which delivers ACT through a 12-week self-guided programme.
The FDA De Novo authorisation of Stanza follows results from multiple randomised controlled trials and real-world studies, including PROSPER-FM; the largest device trial undertaken to date for fibromyalgia treatment. The trial showed that 73% of patients improved in fibromyalgia symptoms by the end of the programme. As well as demonstrating its efficacy, the trials showed Stanza’s low-risk safety profile, with no treatment-related adverse events reported.
According to the company’s press release, “this represents a major milestone both for our company and the fibromyalgia patients we serve, and is a big step towards meaningfully addressing patient access barriers by making evidence-based, non-drug treatments available to more people.”
Betsy Goodfellow
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