Today marks an important milestone at Swing Therapeutics: Stanza, the first prescription digital therapy for fibromyalgia patients in the U.S., is now commercially available.
Fibromyalgia is a chronic, widespread pain condition that affects about 10 million people in the U.S. In addition to experiencing chronic pain, people with fibromyalgia can be challenged by fatigue, difficulty sleeping, reduced daily functioning, difficulty concentrating (“brain fog”), and the mental and emotional health challenges that naturally can arise from these symptoms. For those with fibromyalgia or who have a friend or family member with the condition, you know how much it can get in the way of living the life you want to lead.
Leaders in the field have recognized that the best treatment for fibromyalgia combines both drug and non-drug approaches, including Cognitive Behavioral Therapy (CBT) and a specialized form of it called Acceptance and Commitment Therapy (ACT). However, far too frequently, patients are only prescribed drugs with modest efficacy, recommended exercise, and wished the best of luck. With the launch of Stanza, we intend to change that.
Stanza is making ACT more accessible through a patient-friendly, engaging smartphone application designed for daily use. It is intended to improve the psychological symptoms associated with fibromyalgia, including anxiety, depression, and sleeplessness, in adult patients.
ACT teaches acceptance and mindfulness strategies for symptoms that aren’t controllable. Together with commitment and behavior-change strategies, ACT has been shown to increase quality of life, improve physical and emotional well-being, and reduce the interference of pain in one’s life.
It has been a journey to reach this point. We have created 17 software releases of Stanza and have initiated 7 clinical trials. In our clinical studies to date, patients using Stanza have shown improvement in overall patient well-being as well as other important health measures, including sleep, depression, and anxiety.
We are making Stanza available under the FDA’s Digital Health Enforcement Policy for Digital Health Devices that allows for certain types of digital therapies to be accessible to patients ahead of FDA clearance during the COVID-19 public health emergency. We are concurrently running a multi-site randomized controlled clinical study which we intend to use to support a broader FDA clearance of the treatment.
For fibromyalgia patients, we want you to know that you are not alone and we hear you. Thank you to the Swing Therapeutics team, our amazing advisors, investors, and most importantly, the patients who have worked with us and tested Stanza. We’re excited for a future where everyone who is managing fibromyalgia has access to high-quality treatment and the opportunity to live the life they want.
To learn more about Stanza and how to access the treatment, visit the Stanza webpage.