Swing Therapeutics has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for Stanza, the first prescription digital therapeutic (PDT) designed to treat symptoms of fibromyalgia. Delivered through a smartphone-based platform, Stanza offers a self-guided 12-week program using Acceptance and Commitment Therapy (ACT), a form of Cognitive Behavioral Therapy (CBT) that has shown significant effectiveness in managing chronic pain symptoms. Rachel Hastings, Managing Partner at DelRicht Research, emphasized the importance of expanding non-drug treatment options for chronic pain and credited DelRicht’s diverse investigator network for supporting the pivotal studies that led to this first-in-class authorization.

DelRicht Research contributed to the pivotal clinical studies supporting this clearance through the efforts of several experienced principal investigators:

Dr. Robert Springer of Springer Wellness and Restorative Health in Atlanta, GA
Dr. Taylor Sanders of Neighborhood Health in Prairieville, LA
Dr. Jennifer Zomnir of Zomnir Family Medicine in Prosper, TX
Dr. Sean Kerby of Gulfport Memorial in Gulfport, MS
Dr. Patrick Dennis of Touro Medical Center in New Orleans, LA
Dr. Rachael Murphy of The Murphy Clinic in Mandeville, LA
Dr. Melita Tate of Grassroots Healthcare in Tulsa, OK

A Clinical Milestone for Fibromyalgia

Fibromyalgia affects more than 10 million Americans and is often accompanied by pain, fatigue, and reduced quality of life. Historically underserved and stigmatized, patients with fibromyalgia have had few effective, accessible treatment options, especially those not involving medication. Stanza’s FDA clearance is supported by data from multiple randomized controlled trials, including the landmark PROSPER-FM study, the largest device trial to date for this condition.

Among the 73% of patients who experienced improvement in their symptoms, the use of Stanza demonstrated that non-drug therapies delivered digitally can achieve meaningful outcomes. With no treatment-related adverse events reported, the trial reinforced Stanza’s favorable safety profile. DelRicht’s network of sites helped enroll a diverse group of participants, reflecting a wide range of real-world patient experiences and challenges.

Rachel Hastings on New Hope for Patients in Need

Stanza stands apart as a first-of-its-kind smartphone-based prescription therapy, offering evidence-based behavioral support to patients who may not have access to specialized care. For those who have not responded to traditional medications or who struggle with side effects, Stanza provides an empowering alternative that can be used at home on a flexible schedule. “We are proud to have contributed to the development of this important treatment,” said Rachel Hastings, Managing Partner at DelRicht Research. “The approval of Stanza reflects our continued commitment to bringing innovative therapies to patients and advancing clinical research that meets people where they are. Fibromyalgia patients deserve real solutions, and this is a meaningful step forward.”

“We are proud to have contributed to the development of this important treatment. The approval of Stanza reflects our continued commitment to bringing innovative therapies to patients and advancing clinical research that meets people where they are. Fibromyalgia patients deserve real solutions, and this is a meaningful step forward.”

— Rachel Hastings, Managing Partner at DelRicht Research

Innovation Through Partnership

The development and approval of Stanza highlight the potential of digital therapeutics to transform care, especially for conditions like fibromyalgia that lack consistent access to multimodal treatment. The collaboration between Swing Therapeutics and DelRicht Research exemplifies how local site networks can help bring cutting-edge care to underserved patient populations across the U.S. Dr. Jennifer Zomnir, Principal Investigator at Zomnir Family Medicine in Prosper, TX, noted, “Many of my patients with fibromyalgia have spent years searching for effective treatment. Being part of this trial and seeing a tool like Stanza become available is truly rewarding.”

“Many of my patients with fibromyalgia have spent years searching for effective treatment. Being part of this trial and seeing a tool like Stanza become available is truly rewarding.”

— Dr. Jennifer Zomnir, Principal Investigator at DelRicht Research

As the first FDA-cleared prescription digital therapeutic for fibromyalgia, Stanza marks a pivotal moment in patient care. DelRicht Research is proud to support breakthrough therapies like this, helping accelerate access to safe, scalable solutions for chronic pain conditions. With continued collaboration, these innovations can redefine treatment standards and empower more patients to regain control of their lives.

Read the full press release from Swing Therapeutics.