FDA Clears Freespira Digital Therapeutic for Post-Traumatic Stress Disorder

Palo Alto Health Sciences announced that the FDA has granted clearance to Freespira, a new digital therapeutic for the treatment of PTSD.

Palo Alto Health Sciences announced that the Food and Drug Administration (FDA) has granted clearance to Freespira, a new digital therapeutic for the treatment of post-traumatic stress disorder (PTSD). 

Freespira is a 4-week, drug-free treatment for PTSD, panic disorder, panic attacks, and other panic symptoms. Patients complete two 17-minute in-home sessions every day for 4 weeks under the supervision by a licensed healthcare provider. The therapy helps the patient to stabilize and normalize abnormal respiratory patterns associated with these conditions by training their breathing rate and exhaled carbon dioxide levels.  

The efficacy of Freespira was evaluated in a clinical trial at the Veterans Administration Palo Alto Health Care System in veterans and non-veterans who had PTSD. The primary endpoint was the reduction in patients’ CAPS-5 score, a standardized in-person validated clinical assessment tool for measuring PTSD severity. A response was defined as a reduction in ≥6 points, and remission was defined as a response with no longer meeting clinical symptom criteria and having a CAPS-5 score <25. 

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The data showed a large proportion of patients achieving the 6-point reduction in CAPS-5 score at 2 months (93%) and 6 months (91%)  post-treatment, meeting the primary endpoint. Also, 86% of patients showed a 13-point reduction in the CAPS-5 score at 6 months. A sustained remission was seen in half of patients until at least 6 months post-treatment, as they no longer met the diagnostic criteria. Patient satisfaction was reported to be 90% at 6 months post-treatment and the mean adherence to the treatment protocol was 77%. 

According to the VA/DOD Clinical Practice Guidelines for Management of PTSD, medications are no longer recommended as first-line due to adverse effects and limited efficacy. Compared with exposure-based treatments, use of Freespira allows patients to avoid revisiting the traumatic memories that are common in treatment with exposure therapy while reducing the need for specialists and long-term time investment needed with that type of therapy. 

For more information call (800) 735-8995 or visit Freespira.com.