Pear Therapeutics, Inc. today announced that the Galien Foundation has awarded the 2020 Prix Galien USA Award for Best Digital Health Product to Somryst™, the first FDA-authorized prescription digital therapeutic (PDT) for patients with chronic insomnia. The award, announced at the Prix Galien USA Awards Virtual Ceremony on October 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,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “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.
Somryst is a 9-week Prescription Digital Therapeutic (PDT) for chronic insomnia. Somryst can be used on a mobile device, such as a smartphone or tablet. Somryst is available by prescription only. A licensed Health Care Provider (HCP) must prescribe Somryst and use of Somryst should be undertaken only under the supervised care of an HCP.
Somryst Indications for Use and Important Safety Information
Somryst™ is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia – CBT-I) to patients 22 years of age and older with chronic insomnia. Somryst treats patients with chronic insomnia by improving a patient’s insomnia symptoms.
Safety Information and Warnings
Somryst™ is not for everyone. Please use your clinical judgement to determine whether Somryst is right for your patient.
● Somryst is not for emergency use. Please instruct patients to dial 911 or to go to the nearest emergency room in the event of a medical emergency,
● Patients should be clearly instructed not to use Somryst to communicate severe, critical, or urgent information to their Health Care Provider.
● Somryst is not meant to be used as treatment without supervision of a Health Care Provider.
● Somryst is not meant to be a substitution for any treatment medication.
● Somryst contains sensitive medical information. Please instruct patients to protect their information by password-protecting their smartphone and tablet, and ensuring no one else may access their device.
● Sleep Restriction (and Consolidation) within Somryst can cause sleepiness, especially in the early stages of using the PDT. Somryst should not be used if the patient needs to be alert or cautious to avoid serious accidents in their job or daily life. Examples include:
○ Long-haul truck drivers
○ Long-distance bus drivers
○ Air traffic controllers
○ Operators of heavy machinery
○ Some assembly line jobs
● The usage data collected in therapy lessons by Somryst are not intended to be used as a standalone assessment of treatment progress.
This press release does not include all the information needed to use Somryst safely and effectively. Please see the full Clinician Brief Summary Instructions for Somryst for more information.
About Pear Therapeutics
Pear Therapeutics, Inc. is the leader in prescription digital therapeutics. We aim to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. reSET®, for the treatment of substance use disorder, was the first digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s reSET-O® is indicated for the treatment of opioid use disorder and Somryst® is indicated for the treatment of chronic insomnia. Pear has a pipeline of products and product candidates across therapeutic areas, including severe psychiatric and neurologic conditions. For more information, visit us at www.peartherapeutics.com.