Pear Therapeutics

reSET® & reSET-O®


PATIENT-FACING APPLICATION


CLINICIAN-FACING APPLICATION

reSET, the first Prescription Digital Therapeutic (PDT) to receive authorization from FDA to improve disease outcomes, is a 90-day PDT for Substance Use Disorder (SUD) intended to provide cognitive behavioral therapy (CBT), as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician.

An associated dashboard for clinicians and other health care providers can be used as part of treatment. The dashboard displays information about patients’ use of reSET, including lessons completed, patient-reported substance use, patient-reported cravings and triggers, compliance rewards, and in-clinic data inputs such as urine drug screen results.

reSET-O, the first PDT to receive Breakthrough Designation and authorized by FDA in December 2018, is an 84-day Prescription Digital Therapeutic (PDT) for Opioid Use Disorder (OUD) intended to increase retention of patients in outpatient treatment by providing cognitive behavioral therapy (CBT), as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician.

An associated dashboard for clinicians and other health care providers can be used as part of treatment. The dashboard displays information about patients’ use of reSET-O, including lessons completed, patient-reported substance use, patient-reported cravings and triggers, patient-reported medication use, compliance rewards, and in-clinic data inputs such as urine drug screen results.

For more information about these products click here: www.resetforrecovery.com

For a brief summary of prescribing information on reSET or reSET-O please see links below:

reSET

reSET-O

reSET IMPORTANT SAFETY INFORMATION

Warnings: reSET is intended for patients whose primary language is English and whose reading level is at the 7th grade level or above and who have access to an Android/iOS tablet or smartphone.

reSET is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).

Clinicians should not use reSET to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.

reSET is not intended to be used as a stand- alone therapy for Substance Use Disorder (SUD). reSET does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.

reSET should not be used by individuals outside active enrollment in a SUD treatment program. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET is not intended to reduce the amount of face-to-face clinician time.

The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12-weeks in the SUD population. The ability of reSET to prevent potential relapse after treatment discontinuation has not been studied.

The effectiveness of reSET has not been demonstrated in patients currently reporting opioids as their primary substance of abuse.

Indications for Use

reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older, who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90-day) prescription-only treatment for patients with Substance Use Disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse.

It is intended to:

  • increase abstinence from a patient’s substances of abuse during treatment, and
  • increase retention in the outpatient treatment program.

Please see Clinician Brief Summary Instructions for reSET.

reSET-O IMPORTANT SAFETY INFORMATION

Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).

reSET-O should not be used by individuals outside active OUD treatment. It is not intended to replace treatment by you, the patient’s medical provider. It should be used as an adjunct to clinician treatment, buprenorphine treatment and contingency management.

reSET-O is not intended to be used as ­­­a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.

Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.

Indications for Use

reSET-O is intended to increase retention of patients with Opioid Use Disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.

Please see Clinician Brief Summary Instructions for reSET-O.