Medical Device Network

Swing publishes Phase III data for fibromyalgia digital therapy

The data from the Phase III study showed the efficacy of Swing’s smartphone-based behavioural therapy, Stanza, in improving fibromyalgia symptoms.

Swing Therapeutics has published positive results from the Phase III trial of its digital therapeutic, Stanza, for the treatment of fibromyalgia symptoms.

The randomised, active control Phase III PROSPER-FM study (NCT05243511) evaluated the effects of a 12-week, self-guided, smartphone-delivered digital therapeutic on fibromyalgia management. The results from the trial were published in the Lancet.

Fibromyalgia is a chronic disorder that causes pain and tenderness throughout the body. This is often accompanied by fatigue, sleep, memory, and mood issues. The disorder has a global prevalence of 2%-4%.

Stanza is a self-guided acceptance and commitment therapy, a type of cognitive behavioural therapy (CBT). The device received a de novo authorisation for treating fibromyalgia symptoms by the US Food and Drug Administration (FDA) in May 2023.

The Phase III trial enrolled 275 patients with fibromyalgia aged 22-75 years. At 12 weeks, 71% of the participants in the Stanza treatment arm reported an improvement in well-being measured using Patient Global Impression of Change (PGIC), compared to 22% in the active control group.

Stanza also exhibited statistically greater improvement compared to the control of fibromyalgia-related symptoms, function, and impact, as well as pain intensity, pain interference, fatigue, sleep disturbance and depression. No device-related safety events were reported.

“Fibromyalgia options are typically limited to a handful of pharmacological interventions that have limited efficacy and that can come with difficult-to-manage side effects,” said Swing CEO Mike Rosenbluth.

“This publication validates Stanza as a guideline-directed, non-drug approach that many patients previously couldn’t access due to few available trained clinicians, geographic limitations, and cost.”

There has been an increase in the number of new digital therapeutics for a variety of conditions. The US digital therapeutics is projected to grow at a compound annual growth rate (CAGR) of 25% from 2022 to 2030. However, reimbursement of these therapies is expected to slow the adoption of these therapies, as per a GlobalData report.

In June 2023, the UK’s National Institute of Health and Care Excellence (NICE) approved nine new digital therapies for patients with mental health illnesses to be used in the country’s National Health Service (NHS). The recommendation includes six therapies for anxiety disorders and three for depression.