Fibromyalgia Digital Therapy Receives FDA Breakthrough Designation

Swing Therapeutics Receives FDA Breakthrough Designation for Fibromyalgia Program

Swing Therapeutics, a digital therapeutics company, has been granted a breakthrough device designation by the FDA for its 12-week smartphone-based program designed to manage fibromyalgia. This marks the company’s inaugural breakthrough designation and precedes a series of planned clinical trials throughout the year.

Company Background and Funding

Founded in 2019, Swing Therapeutics has secured $9 million in seed funding, with JAZZ Venture Partners leading the investment. The company’s core focus lies in the treatment of chronic pain conditions, with a specific emphasis on fibromyalgia.

Program Origins and Licensing

The FDA designation applies to the company’s smartphone adaptation of an Acceptance and Commitment Therapy (ACT) program. This original program was initially developed and validated at the University of Manitoba. Swing Therapeutics has obtained exclusive licensing rights and subsequently modified the program for mobile delivery.

According to Mike Rosenbluth, founder and CEO of Swing Therapeutics, the company built upon the foundational work of the University of Manitoba program. They adapted it to create an optimal user experience for contemporary smartphone interfaces.

Expedited FDA Review

This breakthrough designation will facilitate an expedited review process for Swing Therapeutics as they proceed with clinical trials evaluating the product’s efficacy.

Current Fibromyalgia Treatments

Currently, there is no definitive cure for fibromyalgia. However, the FDA has approved three medications to help manage its symptoms. These include Lyrica, commonly prescribed for nerve damage; Cymbalta, initially developed for depression, anxiety, and diabetic neuropathy; and Savella, an SSRI similar to those used in depression treatment.

The Role of ACT in Chronic Pain Management

Beyond pharmaceutical interventions, evidence suggests that ACT can be beneficial for individuals living with chronic pain, including fibromyalgia.

A meta-review analyzing 25 studies on ACT and chronic pain indicated modest effects on pain intensity. However, the therapeutic approach of encouraging patients to accept their pain – without necessarily ignoring it – correlated with substantial and sustained improvements in depression, anxiety, and overall quality of life.

How ACT Works

“ACT aims to assist individuals in accepting symptoms and factors beyond their control,” explains Rosenbluth. “It encourages reflection on personal values and then guides behavior changes aligned with those values.”

Swing Therapeutics’ Platform Design

The Swing Therapeutics platform is intended for prescription by healthcare professionals as a treatment management tool. Upon prescription, patients engage in a 41-session ACT program delivered entirely through their smartphones, structured into “daily doses.” These doses may include mindfulness exercises or brief writing prompts.

Validation of the University of Manitoba Program

The University of Manitoba program, which serves as the basis for Swing’s smartphone application, has been the subject of a randomized controlled trial. The initial validation study involved 67 participants who received either standard care or standard care supplemented with ACT delivered via an eight-week online course.

Completion of the course was associated with improvements in depressive symptoms and enhanced scores on the Fibromyalgia Impact Questionnaire (FIQ-R), which assesses the impact of fibromyalgia on sleep, pain perception, fatigue, and psychological well-being. The course appeared to foster improved “pain acceptance,” thereby influencing the experience of fibromyalgia.

Differences Between Programs and the Need for Further Trials

While the Swing Therapeutics program is based on the University of Manitoba program, it differs in its intended usage. It is designed for near-daily engagement over 12 weeks on a smartphone, compared to the original eight-week computer-based course. These modifications necessitate independent clinical trials to confirm that this specific ACT therapy approach remains effective for fibromyalgia patients.

Ongoing and Planned Clinical Trials

Swing Therapeutics is currently conducting several clinical trials at various stages of completion.

This spring, enrollment concluded for a 67-participant pilot study evaluating their adapted fibromyalgia treatment (participants were assigned to either an active control group or the ACT digital therapy). This study is currently in progress.

Last week, the company initiated a large-scale study, REACT-FM, aiming to enroll between 100 and 150 patients who will utilize the ACT product for twelve weeks.

Furthermore, the company is in the development phase for a Phase 3 randomized controlled trial. Following the completion of this study, Swing Therapeutics intends to submit an application to the FDA for full platform approval. Rosenbluth anticipates launching this study later this year.

Benefits of the Breakthrough Therapy Designation

The FDA breakthrough therapy designation has already proven valuable in shaping these studies. The designation ensures continued expedited review throughout the trial process, potentially streamlining the platform’s path through clinical evaluation.

“The ability to maintain open communication with the FDA has been incredibly helpful,” says Rosenbluth. “It allows us to ensure alignment in clinical study design and that our approaches meet the FDA’s expectations.”