Swing Therapeutics’ Stanza is a self-guided acceptance and commitment therapy, a type of cognitive behavioural therapy (CBT), for treating fibromyalgia symptoms. Image credit: Gladskikh Tatiana / Shutterstock

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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 Mike Rosenbluth, CEO of Swing.

“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.

GlobalData is the parent company of Clinical Trials Arena.

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.