Stanza demonstrated significant improvements compared to an active control on virtually all endpoints, including fibromyalgia-related well-being, pain intensity, pain interference, fatigue, and depression.
The self-guided, smartphone-based program, which delivers Acceptance and Commitment Therapy, expands access to guideline-directed management of fibromyalgia, with no adverse effects observed.
Stanza received FDA De Novo marketing authorization in 2023, as the first digital therapeutic indicated for treating fibromyalgia symptoms.
Stanza is available by prescription through Swing Care, a virtual specialty clinic focused on comprehensively treating fibromyalgia.
SAN FRANCISCO – Swing Therapeutics, a leading developer of digital treatments and virtual care services for chronic pain patients, today announced the publication of data in The Lancet from its pivotal Phase 3 trial of Stanza, a self-guided smartphone-based behavioral therapy for the treatment of fibromyalgia symptoms.
The manuscript describes results from PROSPER-FM, a multi-center, randomized controlled trial. It clinically validates Stanza’s benefits, including improvements in well-being (measured by Patient Global Impression of Change), fibromyalgia severity (measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)), and major fibromyalgia symptoms including pain intensity, pain interference, fatigue, sleep disturbance, depression and physical function. This is the largest study on an FDA-cleared medical device for fibromyalgia that has ever been undertaken.
“For millions of people with fibromyalgia, this study, published in The Lancet, describes a new and effective therapy for fibromyalgia,” said Principal Investigator, Lesley M. Arnold, MD, Professor Emerita at the University of Cincinnati College of Medicine. “This novel, non-drug therapy, available using a smartphone, makes management of fibromyalgia more accessible and convenient. This offers new hope for people with fibromyalgia, who have continued to experience unmet treatment needs.”
In the 12-week trial, 275 participants were randomized to receive either Stanza treatment or a digital symptom tracker control. At week 12, 70.6% of participants in the Stanza arm reported an improvement on PGIC (vs 22.2% in the control arm, p < .001). Stanza exhibited statistically greater improvement compared to the control on the FIQ-R total score (p < .001, Effect Size = .65). Statistical superiority was found on virtually all endpoints, including FIQ-R “function”, “overall impact”, and “symptoms” domains, pain intensity, pain interference, Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Sleep Disturbance domains, Beck Depression Inventory II (BDI II), Psychological Inflexibility in Pain Scale (PIPS), and the Committed Action Questionnaire (CAQ-8). No treatment-related adverse events were observed.
Stanza delivers acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy (CBT) recommended by international clinical guidelines for fibromyalgia management with Level 1A evidence. It received FDA De Novo marketing authorization for the treatment of fibromyalgia symptoms in May 2023.
“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.”
In an effort to expand access to comprehensive fibromyalgia care, Swing developed Swing Care, a specialty virtual care platform. Results from Swing Care presented at the Society of Behavioral Medicine in January 2024 support meaningful improvement among patients who receive multimodal care for fibromyalgia, inclusive of Stanza. 81% reported improvement in well-being, as measured by Patient Global Impression of Change (PGIC) at 90 days.
The manuscript on the pivotal study of Stanza, titled “Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial” is available online at https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00909-7/fulltext
About Fibromyalgia
Fibromyalgia is a chronic pain condition that affects an estimated 10 million Americans, a majority of whom are women. The condition is characterized by widespread pain and other physical and cognitive symptoms that include fatigue, disrupted sleep, reduced physical function, memory problems and difficulty concentrating (“brain fog”), and is often accompanied by anxiety and depression.
About Swing Therapeutics and Swing Care
Swing was founded in 2019 with the goal of developing evidence-based digital treatments and virtual care services to help people with chronic illness live their best lives. Stanza is an FDA-cleared digital behavioral therapy for treatment of fibromyalgia symptoms. To learn more about Stanza, visit swingtherapeutics.com
Stanza is available by prescription through Swing Care, a specialty clinic that offers comprehensive treatment for fibromyalgia. Clinical protocols were developed by Medical Director Dr. Andrea Chadwick, a globally recognized expert in fibromyalgia care. To learn more about Swing Care, visit swing.care
About University of Cincinnati
Founded in 1819, the University of Cincinnati ranks among the nation’s best urban public research universities. The University of Cincinnati is classified as a Research 1 institution by the Carnegie Commission and is ranked in the National Science Foundation’s Top-35 public research universities. UC’s medical, graduate and undergraduate students and faculty investigate problems and innovate solutions with real-world impact. Learn more at uc.edu