Key Highlights
- Swing Therapeutics announces positive results from the Phase 3 PROSPER-FM trial of Stanza, a digital therapy for fibromyalgia.
- Stanza receives FDA De Novo marketing authorization, marking it as the first digital therapeutic for fibromyalgia symptoms.
- The PROSPER-FM trial demonstrates significant improvements in fibromyalgia symptoms, including pain, fatigue, and sleep disturbances.
Source: Business Wire
Notable Quotes
- “Managing fibromyalgia is not as simple as taking a pill… With these pivotal RCT results, we have established that Stanza offers outcomes that meaningfully improve patients’ lives.” – Dr. Michael Rosenbluth, PhD, CEO at Swing Therapeutics
- “The outcomes from PROSPER-FM… show that the Stanza program is a terrific new option to deliver these types of therapies to patients.” – Dr. Dan Clauw, Director, Chronic Pain Research Center at University of Michigan
- “The digital therapy, with an excellent benefit-to-risk profile, offers an important step forward in reaching and benefiting the broader fibromyalgia population.” – Lesley Arnold, MD, Professor Emerita at University of Cincinnati College of Medicine
SoH's Take
The FDA’s authorization of Stanza by Swing Therapeutics marks a significant milestone in the management of fibromyalgia, a condition that has long challenged the medical community due to its complexity and multifaceted symptoms. This innovative digital therapy represents a paradigm shift, emphasizing the role of cognitive behavioral therapies in managing chronic pain conditions. Its successful trial outcomes underscore the potential of digital therapeutics in providing accessible, effective, and non-pharmacological options for patients. As healthcare continues to embrace digital transformation, Stanza’s success story could pave the way for more such interventions, fundamentally altering the landscape of chronic pain management.
