RESET® and RESET-O® can help more people who are
struggling with addiction start and stay in treatment.*
*During 12 weeks of treatment.
THE CHALLENGE
Most individuals who meet the criteria for opioid and substance use disorders never receive proper treatment1
†MAT includes buprenorphine, methadone, or naltrexone plus psychosocial support.2
Prescription Digital Therapeutics (PDTs) leverage software to enhance how we treat human disease
TREATMENT CHALLENGES
Staying in treatment is critical for people on their recovery journey
While there’s widespread acknowledgement that millions of Americans struggle with a range of substance use disorders, there’s less awareness that the majority of them are not receiving proper care. Consider the statistics:
- Of the 20.4 million Americans living with substance use disorder in 2019,3 only 20% received any formal treatment
- Of the 2.1 million Americans living with opioid use disorder in 2019,3 only 20% received specialty addiction treatment4
Today, patients with substance use disorder and opioid use disorder face a critical lack of treatment programs, uncertain economic futures, and difficulty accessing in-person care. At the same time, providers are looking to augment their remote care capabilities to keep up with a dramatic surge in demand.5
BARRIES TO CARE
Clinicians face significant barriers to providing therapy
Social Stigma
14.9% of adults who feel they need treatment for substance use cite the possible negative opinion of their community as a reason for not receiving treatment.3
Access to Therapy
A study cites 64% (n=50) of physicians who don’t prescribe buprenorphine reported lack of mental health and psychosocial support for patients as a perceived obstacle to prescribing.6
Gaps in Care
Care transitions are critical moments for patients receiving treatment for substance use. Reduced touch points between intensive inpatient care to outpatient care settings can lead to patient dropout.7
ABOUT PRESCRIPTION DIGITAL THERAPEUTICS
What is a prescription digital therapeutic?
It is a new therapeutic class that is being integrated into standard of care.
FDA-authorized prescription digital therapeutics
Innovative treatment designed for the way people live today
- Clinically validated treatments
- 24/7 access to care
- Accessible by smartphone or tablet
- Real-world engagement data
Unlike traditional wellness apps, prescription digital therapeutics undergo rigorous regulation and testing
MEET THE UNMET NEED
Why choose prescription digital therapeutics?
Prescription digital therapeutics provide novel therapy options for unmet medical needs. They can be used to enhance or support treatment and:
- Increase accessibility and may reduce the stigma usually associated with therapeutic treatment
- Foster engagement by integrating gaming, social technologies, and incentives into therapy
- Make it easy to control quality through consistent delivery of evidence-based therapy
- Allow clinicians to customize treatment sessions according to patient-reported feelings, behavior, and activities throughout the week
RESET® 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.
RESET® Important Safety Information for Patients:
Warnings/precautions: Do not use RESET to communicate any emergency, urgent or critical information. RESET does not include features that can send alerts or warnings to your clinician. If you have feelings or thoughts of harming yourself or others, please dial 911 or go to the nearest emergency room.
RESET is intended for patients whose primary language is English with a reading level of 7th grade or above, who have access to an Android/iOS tablet or smartphone, and who are familiar with the use of smartphone applications (apps). You should be able to upload data periodically, i.e. have internet/wireless connection access.
RESET is not intended to be used as stand-alone therapy for substance use disorder (SUD) and does not replace care by your provider or outpatient treatment. RESET is not a substitute for your medications. You should continue to take your medications as directed by your provider.
The long-term benefit of treatment with RESET on abstinence has not been evaluated in studies lasting beyond 12 weeks (90 days) in the SUD population. The ability of RESET to prevent potential relapse after treatment discontinuation has not been studied.
The safety and effectiveness of RESET has not been established in patients enrolled in opioid treatment programs reporting opioids as their primary substance of abuse.
RESET-O® Indications for Use:
RESET-O prescription digital therapeutic is a 12-week (84 day) software application 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.
RESET-O® Important Safety Information for Patients:
Warnings/precautions: Do not use RESET-O to communicate any emergency, urgent or critical information. RESET-O does not include features that can send alerts or warnings to your clinician. If you have feelings or thoughts of harming yourself or others, please dial 911 or go to the nearest emergency room.
RESET-O is intended for patients whose primary language is English with a reading level of 7th grade or above, who have access to an Android/iOS tablet or smartphone, and who are familiar with the use of smartphone applications (apps). You should be able to upload data periodically, i.e. have internet/wireless connection access.
RESET-O is not intended to be used as stand-alone therapy for Opioid Use Disorder (OUD) and does not replace care by your provider or outpatient treatment. RESET-O is not a substitute for your medications. You should continue to take your medications as directed by your provider.
The long-term benefit of RESET-O has not been evaluated in studies lasting beyond 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
References:
1. Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results From the 2020 National Survey on Drug Use and Health. US Department of Health and Human Services; 2021. HHS publication no. PEP21-07-01-003, NSDUH Series H-56. Accessed April 15, 2022.
https://www.samhsa.gov/data/sites/default/files/reports/rpt35325/NSDUHFFRPDFWHTMLFiles2020/2020NSDUHFFR1PDFW102121.pdf
2. Medication-assisted treatment (MAT). Substance Abuse and Mental Health Services Administration. Updated March 30, 2022. Accessed April 15, 2022.
https://www.samhsa.gov/medication-assisted-treatment
3. Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results From the 2019 National Survey on Drug Use and Health. US Department of Health and Human Services; 2020. HHS Publication No. PEP20-07-01-001, NSDUH Series H-55. Accessed May 4, 2020. https://www.samhsa.gov/data/sites/default/files/reports/rpt29393/2019NSDUHFFRPDFWHTML/2019NSDUHFFR090120.htm
4. McCance-Katz EF. SAMHS/HHS: an update on the opioid crisis. Presented at: American Association for the Treatment of Opioid Dependence Conference; March 12-14, 2018; New York, NY. Accessed June 10, 2020. https://www.samhsa.gov/sites/default/files/aatod_2018_final.pdf
5. Center for Substance Abuse Treatment. Substance Abuse: Clinical Issues in Intensive Outpatient Treatment. Treatment Improvement Protocol (TIP) Series 47. DHHS Publication No. (SMA) 06-4182. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2006.
6. Hutchinson E, Catlin M, Andrillas CHA, Baldwin LM, Rosenblatt RA. Barriers to primary care physicians prescribing buprenorphine. Ann Fam Med. 2014;12(2):128-133.
7. Forman RF, Nagy PD. Substance Abuse: Clinical Issues in Intensive Outpatient Treatment. Treatment Improvement Protocol TIP 47. Rockville, MD: U.S. Dept. of Health and Human Services. 2006. DHHS Publication No. (SMA) 06-4182.
8. Campbell ANC, Nunes EV, Matthews AG, et al. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014;171(6):683-690.
9. Christensen DR, Landes RD, Jackson L, et al. Adding an internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972.
10. FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs. News release. Silver Spring, MD: US Food and Drug Administration. December 10, 2018. Accessed May 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-clears-mobile-medical-app-help-those-opioid-use-disorder-stay-recovery-programs
11. FDA permits marketing of mobile medical application for substance use disorder. News release. Silver Spring, MD: US Food and Drug Administration. September 14, 2017. Accessed May 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-mobile-medical-application-substance-use-disorder
12. AMCP Partnership Forum: Digital Therapeutics—What Are They and Where Do They Fit in Pharmacy and Medical Benefits? J Manag Care Spec Pharm. 2020;26(5):674-681.