FDA clears Freespira- A digital solution for Post-traumatic stress disorder

The U.S FDA has granted clearance to Freespira, a new digital therapeutic for the treatment of post-traumatic stress disorder (PTSD), announced Palo Alto Health Sciences.

Freespira is used in treatment for PTSD, panic disorder, panic attacks, and other panic symptoms. Treatment entails two 17-minute in-home sessions daily for four weeks and is authorized and completed under the supervision of a licensed healthcare provider. Freespira corrects the abnormal respiratory patterns associated with these conditions by training the user to stabilize and normalize their breathing rate and exhaled CO2 levels.

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A clinical trial was conducted at the Veterans Administration Palo Alto Health Care System to demonstrate the efficacy of Freespira for veterans and non-veterans suffering from PTSD. The primary endpoint of this study was to determine if treatment with Freespira could reduce the patient's CAPS-5 score. CAPS-5 is a standardized in-person validated clinical assessment tool for measuring the severity of PTSD. The response was defined as a reduction of six or more points. Remission was defined as response plus no longer meeting clinical symptom criteria and having a CAPS-5 score < 25.

The study met its primary endpoint with a large majority of subjects achieving the specified 6-point reduction in the CAPS-5 score at two months and six-months post-treatment (93% and 91% respectively). Importantly, 86% of patients had a 13-point reduction in the CAPS-5 score at 6 months. In addition, 50% of the patients no longer met the diagnostic criteria for PTSD, thus providing them with sustained remission of their PTSD until at least six months post-treatment. Patient satisfaction was 90% at six months post-treatment. Furthermore, mean patient adherence to the treatment protocol was 77%. Based on these results, FDA-cleared Freespira to treat PTSD

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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.

“PTSD is extremely difficult to treat. The availability of an effective, four-week, drug-free intervention is a game changer for people suffering from PTSD. Freespira offers hope for people who otherwise experience a significantly diminished quality of life," said principal investigator Michael Ostacher.

Freespira is currently commercially available for panic throughout the U.S. and will be available for PTSD in the second half of 2019.