This week, Swing Therapeutics received De Novo marketing authorization by the U.S. Food and Drug Administration (FDA) for Stanza, the first prescription digital therapeutic for treating fibromyalgia symptoms. This represents a major milestone both for our company and the fibromyalgia patients we serve, and is a big step towards meaningfully addressing patient access barriers by making evidence-based, non-drug treatments available to more people.
Fibromyalgia is a chronic pain condition that affects over 10 million Americans. If you experience fibromyalgia or know someone with the condition, you know how life-changing it can be. On top of dealing with the debilitating symptoms, fibromyalgia patients have been historically underserved and even stigmatized. Current FDA-approved medications, while offering moderate efficacy, are often accompanied by side effects.
Treatment guidelines recommend multimodal care that combines medications with non-drug approaches, including Cognitive Behavioral Therapy (CBT) and a specialized form of it called Acceptance and Commitment Therapy (ACT). But access to these non-drug approaches has been extremely limited for most people. Too often, fibromyalgia patients are prescribed drugs, told to exercise, and then tasked with figuring out how to manage their disease on their own.
At Swing, we believe that people with fibromyalgia deserve more. Stanza is a smartphone-based prescription digital therapeutic (PDT) that delivers ACT for treatment of fibromyalgia symptoms through a 12-week self-guided program. ACT has been shown in multiple randomized controlled trials to be effective in reducing the severity of fibromyalgia symptoms.
Leading up to FDA De Novo granting of Stanza, Swing ran multiple randomized controlled trials and real-world studies, including PROSPER-FM, the biggest device trial ever undertaken for fibromyalgia treatment. Our published trial results showed strong treatment effectiveness, with 73% of patients improving in fibromyalgia symptoms (measured by Patient Global Impression of Change) by the end of the program.¹ The trials also demonstrated Stanza’s low-risk safety profile, with zero treatment-related adverse events reported during these studies.
Prescription digital therapeutics (PDTs) have seen significant challenges in recent months. Pioneers in the industry have demonstrated the real-world efficacy of digital therapeutics on patient outcomes, but have not yet seen a proportionate response from payers to cover these treatments. Swing Therapeutics is working on making a rigorous case for clinical and economic value by building robust clinical evidence and demonstrating the positive impact on patients’ lives.
We are also working to solve the broader challenge in fibromyalgia treatment of patients lacking a medical home, one that offers tailored, evidence-based, comprehensive treatments. To help realize this mission, we have launched Swing Care, a virtual care platform that enables the delivery of personalized, holistic care to patients with fibromyalgia, with Stanza as a treatment option. The response from patients has emphasized the power of this approach, from getting personalized treatment to finally feeling like a doctor understands.
Stanza is currently available to Texas patients through Swing Care, and will be available in more states later this year. To learn more about Swing Care, visit https://www.swing.care. To learn more about Stanza, visit https://www.swingtherapeutics.com/stanza.
¹ Rosenbluth M, Catella S, Gendreau R, Kraus A, Vega N, Soefje S, Shishuka M, Luciano J, McCracken L, Williams D, Arnold L. Self-Guided Digital Acceptance and Commitment Therapy for Fibromyalgia Management: Results of a Randomized, Controlled, Pilot Clinical Trial. IASP September 2022.