Pear Therapeutics is seeking marketing authorization from the Food and Drug Administration (FDA) for Somryst, a prescription digital therapeutic (PDT) intended for use in the treatment of adults with chronic insomnia and depression.
Somryst works by reducing symptoms of depression and the severity of insomnia through neurobehavioral interventions, specifically cognitive behavioral therapy for insomnia (CBTi) and a sleep restriction algorithm.
The FDA submission is supported by data from 2 clinical trials which evaluated the efficacy of the investigational PDT in approximately 1100 adult patients with chronic insomnia and depression over the course of 9 weeks. Patients were randomized to receive either the PDT or an attention-matched digital placebo along with usual care. Study outcomes were measured at baseline, at 9 weeks, and post-treatment at 6 months, 12 months, and 18 months.
Results showed that at the end of 9 weeks, patients in the PDT arm showed a reduction in mean Insomnia Severity Index (ISI) score to 7.27, from baseline of mean 15.92, while those in the placebo group showed a reduction in ISI score to a mean of 13.17, from a baseline of mean 16.23 (LS mean difference: -5.90, (95% CI, -6.68, -5.11); P <.0001). PDT treatment was also associated with a reduction in depression severity as measured by the Patient Health Questionnaire 9 (PHQ9) (mean score of 3.78 from a baseline mean of 8.03 vs 6.20 from a baseline mean of 7.84 for placebo; LS mean differences -2.42, [95% CI, -3.01, -1.83]; P <.0001).
Moreover, patients in the treatment arm showed improvements in both anxiety symptoms (LS mean differences in General Anxiety Disorder 7-item scale: -1.83, [95% CI, -2.41, -1.25]; P <.0001) and suicidal ideation (LS mean differences in Psychiatric Symptom Frequency Scale: -0.29, [95% CI, -0.53, -0.06], P = 0.0147), compared with placebo.
“Most adults with insomnia receive medication intended for short-term use or struggle with insomnia without receiving effective, lasting treatment. Somryst could facilitate patient access to CBTi treatment with appropriate clinical oversight and management from clinicians,” said Dr Charles M. Morin, PhD, Professor of Psychology, Director Sleep Research Centre at Université Laval in Quebec City.
For more information visit peartherapeutics.com.