SAN FRANCISCO–(BUSINESS WIRE)–Swing Therapeutics, a leading developer of digital therapies for chronic pain conditions, today announced the successful completion of and positive results from its pivotal Phase 3 PROSPER-FM trial on Stanza, a self-guided smartphone-based behavioral therapy for the treatment of fibromyalgia symptoms in adult patients. Results from this multi-center, randomized controlled trial (RCT) were presented at the American College of Rheumatology (ACR) 2023 annual meeting this week.
Swing received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for Stanza in May 2023, making it the first prescription digital therapeutic indicated for treating fibromyalgia symptoms. It delivers acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy (CBT) with proven efficacy in treating fibromyalgia and other chronic pain conditions.
“Managing fibromyalgia is not as simple as taking a pill. Unfortunately, access to clinically validated non-drug treatments has been extremely limited, despite their effectiveness,” said Dr. Michael Rosenbluth, PhD, CEO of Swing. “With these pivotal RCT results, we have established that Stanza offers outcomes that meaningfully improve patients’ lives, through a self-guided program that can increase access.”
The results from the pivotal PROSPER-FM trial, the largest RCT undertaken on fibromyalgia treatment devices, confirmed Stanza’s clinical benefits, including improvements in well-being (measured by Patient Global Impression of Change), fibromyalgia severity (measured by the Revised Fibromyalgia Impact Questionnaire), and major fibromyalgia symptoms including pain intensity, pain interference, fatigue, sleep disturbance, depression and physical function.
“Clinical guidelines have repeatedly called for the incorporation of non-drug therapies in the treatment of fibromyalgia,” said Dr. Dan Clauw, Director of the Chronic Pain Research Center, University of Michigan. “The outcomes from PROSPER-FM and several other supportive studies show that the Stanza program is a terrific new option to deliver these types of therapies to patients. This helps make the types of recommendations commonly seen in guidelines finally available in many real-life clinical practice settings where these therapies were simply not previously available.”
Digital Acceptance and Commitment Therapy Improves Fibromyalgia Outcomes: Results from a Pivotal, Multi-center, Randomized Controlled Trial
In this 12-week trial, 275 participants were randomized to receive either Stanza treatment or a digital symptom tracker control. The primary outcome measurement was the response rate on the Patient Global Impression of Change (PGIC) Scale. The key secondary endpoint measured fibromyalgia severity using the Revised Fibromyalgia Impact Questionnaire (FIQ-R). The trial also collected additional endpoints on pain intensity, pain interference, fatigue, sleep disturbance, depression, and psychological flexibility.
Analysis of the intention-to-treat population demonstrated significant clinical benefits of Stanza. 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.
The principal investigator of PROSPER-FM, Lesley Arnold, MD, Professor Emerita at University of Cincinnati College of Medicine, stated: “I am pleased to see the trial results demonstrate Stanza’s significant and meaningful clinical impact on virtually all measures. The digital therapy, with an excellent benefit-to-risk profile, offers an important step forward in reaching and benefiting the broader fibromyalgia population with guideline directed non-drug treatments.”
The full publication can be accessed at: https://acrabstracts.org/abstract/digital-acceptance-and-commitment-therapy-improves-fibromyalgia-outcomes-results-from-a-pivotal-multi-center-randomized-controlled-trial/
FDA Authorizes Stanza to Treat Fibromyalgia Symptoms
Swing Therapeutics received FDA De Novo marketing authorization for Stanza in May 2023. The digital therapy is offered by prescription through Swing Care, a clinic that provides comprehensive, personalized fibromyalgia treatment, including medication management and lifestyle coaching, in Illinois, Tennessee and Texas.
“New treatments for fibromyalgia are rare, so providers can feel like they have a limited toolset to address its symptoms,” said Dr. Andrea Chadwick, Medical Director at Swing Care Provider Group. “Stanza’s clinical data makes it a compelling option for both clinicians and patients seeking new approaches to care that are backed by evidence.”
Fibromyalgia is a chronic pain condition that affects an estimated 10 million Americans, 80% 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
Swing Therapeutics was founded in 2019 with the goal of developing evidence-based digital therapies that help people with chronic illness live their best lives. Stanza, an FDA-cleared digital therapy for treatment of fibromyalgia symptoms, is now available by prescription. For more information visit swingtherapeutics.com.
About Swing Care
Swing Care was opened in 2022 to increase access to evidenced-based, comprehensive treatment for patients living with fibromyalgia. Clinical protocols were developed by Medical Director Dr. Andrea Chadwick, a globally recognized expert in fibromyalgia care. It offers services throughout Illinois, Tennessee and Texas. For more information visit swing.care.