Swing Therapeutics Announces Positive Results from Pivotal Phase 3 Trial of Stanza, a Digital Therapy for Fibromyalgia Symptoms
Swing Therapeutics, a leading developer of digital therapies for chronic pain conditions, announced the successful completion of and positive results from its pivotal Phase 3 PROSPER-FM trial on Stanza, a self-guided smartphone-based behavioral therapy for the treatment of fibromyalgia symptoms in adult patients. Swing received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for Stanza in May 2023, making it the first prescription digital therapeutic indicated for treating fibromyalgia symptoms. In this 12-week trial, 275 participants were randomized to receive either Stanza treatment or a digital symptom tracker control. The primary outcome measurement was the response rate on the Patient Global Impression of Change (PGIC) Scale. The key secondary endpoint measured fibromyalgia severity using the Revised Fibromyalgia Impact Questionnaire (FIQ-R). Analysis of the intention-to-treat population demonstrated significant clinical benefits of Stanza. At week 12, 70.6% of participants in the Stanza arm reported an improvement on PGIC. Stanza exhibited statistically greater improvement compared to the control on the FIQ-R total score.
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