At PEAR, we are focused on the development of prescription digital therapeutics to treat diseases with high unmet medical need.
September 14, 2017
PEAR Therapeutics Obtains FDA Clearance of the First Prescription Digital Therapeutic to Treat Disease
PEAR IS A FULLY INTEGRATED, PRESCRIPTION DIGITAL THERAPEUTICS COMPANY
We are developing software-based, prescription digital therapeutics designed to treat severe medical conditions. PEAR is seeking FDA clearance for these products. Our development process examines the clinical impact of these interventions in randomized clinical trials. We strive to provide enhanced outcomes for patients, supportive engagement and tracking tools for clinicians, and cost-effective solutions for payers.
PRESCRIPTION DIGITAL THERAPEUTICS TO TREAT UNMET NEED
PEAR has developed a pipeline of clinically validated, prescription digital therapeutics.
PEAR is also working on Generalized Anxiety Disorder (GAD), post-surgical pain, Major Depressive Disorder (MDD), and insomnia, among other indications.
PEAR’s lead products, reSET® and reSET-OTM have been evaluated in 6 randomized clinical trials involving over 1500 patients.*
THRIVETM has been examined in three clinical studies involving 1,279 patients. Efficacy has been demonstrated as assessed by PANSS (the aggregate approvable endpoint for schizophrenia therapies) and patient engagement has been demonstrated beyond six months.
* Therapeutic Education System (TES), which has equivalent content to reSET®, was tested. Please see labeling for study details.