Galien Foundation has awarded the 2020 Prix Galien USA Award for Best Digital Health Product to Pear Therapeutics Inc’s Somryst, the first Food and Drug Administration (FDA)-authorized prescription digital therapeutic for patients with chronic insomnia. The award, announced at the Prix Galien USA Awards Virtual Ceremony on Oct 29, 2020, recognizes companies and individuals who have impacted patient care through innovation.
“We are honored that Somryst, the only FDA-authorized therapeutic that delivers CBTi, which is the guideline recommended long-term, first-line treatment for chronic insomnia, was awarded the prestigious 2020 Prix Galien USA Award for Best Digital Health Product,” says Corey McCann, MD, PhD, president and CEO of Pear Therapeutics, in a release. “This recognition would not have been possible without the many contributions of the people who work at Pear. We are proud to provide patients with Somryst and continue forward in our efforts to make prescription digital therapeutics standard of care across a range of diseases.”
Somryst, intended for use in the treatment of patients 22 years of age and older with chronic insomnia, treats patients with chronic insomnia by improving a patient’s insomnia symptoms. Somryst was the first product submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program.