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.
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.
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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. (Photo:
Business Wire)
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.
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Swing: Nicole Villeneuve nicole@swingtherapeutics.com
University of Cincinnati Tim Tedeschi
tedesctd@ucmail.uc.edu