Monday, July 15, 2024

Fibromyalgia Digital Therapy: Swing Publishes Promising Phase III Data

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Fibromyalgia management has seen a breakthrough as Swing Therapeutics has recently published positive results from its Phase III trial of Stanza, a digital therapeutic designed to alleviate its symptoms. This randomized, active control Phase III PROSPER-FM study (NCT05243511) evaluated the effectiveness of a 12-week, self-guided, smartphone-delivered digital therapeutic in improving the quality of life for patients with fibromyalgia. The results were published in The Lancet, highlighting the promising potential of digital health solutions in chronic disease management.

Fibromyalgia is a chronic disorder characterized by widespread pain and tenderness, often accompanied by fatigue, sleep disturbances, memory issues, and mood disorders. Globally, fibromyalgia affects approximately 2% to 4% of the population. Traditional treatments have primarily been pharmacological, with limited efficacy and challenging side effects, making non-drug interventions like Stanza a valuable addition to treatment options.

Fibromyalgia Treatment: Stanza’s ACT-Based Digital Therapy Gains FDA Approval and Shows Positive Phase III Results

Stanza utilizes acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), delivered through a smartphone app. The device received de novo authorization from the US Food and Drug Administration (FDA) in May 2023 for treating fibromyalgia symptoms. The Phase III trial enrolled 275 participants aged 22 to 75 years with fibromyalgia, comparing the effects of Stanza to an active control group over 12 weeks.

The results were compelling: 71% of participants in the Stanza treatment arm reported an improvement in well-being, as measured by the Patient Global Impression of Change (PGIC), compared to just 22% in the control group. Additionally, Stanza showed statistically significant improvements across various fibromyalgia-related symptoms, including function, impact, pain intensity, pain interference, fatigue, sleep disturbance, and depression. Importantly, no device-related safety events were reported, underscoring the safety of this digital therapeutic.

Swing Therapeutics CEO, Mike Rosenbluth, emphasized the significance of these findings, stating, “Fibromyalgia options are typically limited to a handful of pharmacological interventions that have limited efficacy and can come with difficult-to-manage side effects. 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.”


Fibromyalgia Digital Therapeutics on the Rise: US Market Projected to Grow Despite Reimbursement Challenges

The rise of digital therapeutics has been notable in recent years, offering new treatment avenues for a variety of conditions. The US digital therapeutics market is projected to grow at a compound annual growth rate (CAGR) of 25% from 2022 to 2030. Despite this growth, the adoption of digital therapies faces hurdles, particularly in terms of reimbursement. According to a GlobalData report, reimbursement issues are expected to slow the adoption rate of these innovative therapies.

In a related development, the UK’s National Institute of Health and Care Excellence (NICE) approved nine new digital therapies in June 2023 for patients with mental health illnesses to be used within the National Health Service (NHS). This recommendation includes six therapies for anxiety disorders and three for depression, reflecting the expanding role of digital health solutions in various medical fields.

The publication of the Phase III data for Stanza marks a significant milestone in the treatment of fibromyalgia. With the evidence supporting its efficacy and safety, Stanza represents a promising non-drug alternative that can be more accessible to patients, overcoming barriers related to geography, availability of trained clinicians, and cost. This aligns with the broader trend towards integrating digital therapeutics into mainstream healthcare, offering patients innovative and effective treatment options for managing chronic conditions.

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As digital health continues to evolve, the successful implementation and acceptance of therapies like Stanza could pave the way for broader applications, enhancing patient care and outcomes across multiple domains. The positive results from the PROSPER-FM study serve as a testament to the potential of digital therapeutics to address unmet needs in chronic disease management, providing hope for millions of patients worldwide.


Resource: Medical Device Network, July 10, 2024

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