BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Pear Therapeutics, Inc. at present introduced the primary participant enrolled within the Nationwide Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN)-0100 examine on optimizing retention, length, and discontinuation methods for pharmacotherapy remedy of opioid use dysfunction (OUD), utilizing Pear’s prescription digital therapeutic (PDT) reSET-O®. Investigators will examine reSET-O, at the side of high- and standard-dose transmucosal buprenorphine, extended-release injectable buprenorphine, and extended-release injectable naltrexone in a multi-site randomized trial. The examine is funded by the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative. NIDA is a part of the Nationwide Institutes of Well being.
The mission of this work is to develop information to tell and enhance OUD remedy methods for sufferers and suppliers. Pear’s participation within the examine is a part of its dedication and management in creating scientific proof throughout affected person populations and pharmacotherapies.
“The final word remedy purpose of sufferers with OUD is sustained retention in remedy, discount of substance use, and improved high quality of life. Pear is dedicated to increasing the scientific proof for our PDTs to higher tackle unmet affected person wants, and we thank the sufferers and investigators collaborating within the CTN-0100 examine,” stated Yuri Maricich, M.D., Chief Medical Officer at Pear Therapeutics. “Via the NIH HEAL Initiative, the Nationwide Institute on Drug Abuse, the biggest supporter of the world’s analysis on drug use and habit, established a scientific trial settlement with Pear for reSET-O to be a part of CTN-0100, an necessary examine devoted to evaluating remedy optionality to enhance outcomes for sufferers with OUD.”
Pear’s FDA-authorized PDTs help affected person and scientific success by inserting evidence-based remedy and remedy accountability within the palm of the affected person’s hand. Via Pear’s reSET-O sufferers have entry to algorithm-driven behavioral therapies which are designed to drive engagement and enhance scientific outcomes1-2. Utilizing the Pear platform, clinicians can monitor affected person remedy compliance and progress. PDTs are designed to gather actual world information to be used by prescribing clinicians and for inhabitants well being administration by payors and well being techniques. Pear intends to extend entry to PDTs by including them to plain formularies.
Disclaimer: The examine described on this press launch is funded and supported by the Clinical Trials Network on the Nationwide Institute on Drug Abuse, a part of the Nationwide Institutes of Well being, (UG1DA013035; UG1DA015831), as part of the NIH HEAL Initiative. The content material on this press launch is solely the accountability of the authors and doesn’t symbolize the official views of the Nationwide Institutes of Well being.
About Pear Therapeutics
Pear Therapeutics is the chief in prescription digital therapeutics, or PDTs. Pear goals to redefine medication by discovering, creating, and delivering clinically validated software-based therapeutics to supply higher outcomes for sufferers, smarter engagement and monitoring instruments for clinicians, and cost-effective options for payers. Pear has a pipeline of merchandise and product candidates throughout therapeutic areas, together with the primary three PDTs with illness remedy claims from FDA. Pear’s lead product, reSET®, for the remedy of substance use dysfunction, was the primary PDT to obtain advertising and marketing authorization from FDA to deal with illness. Pear’s second product, reSET-O®, for the remedy of opioid use dysfunction, was the primary PDT to obtain Breakthrough Designation. Pear’s third product, Somryst® for the remedy of persistent insomnia, was the primary PDT submitted via FDA’s conventional 510(ok) pathway whereas concurrently reviewed via FDA’s Software program Precertification Pilot Program. For extra data, go to Pear at www.peartherapeutics.com.
reSET-O Vital Security Data
Indications for Use:
reSET-O prescription digital therapeutic is a 12-week (84 day) software program utility meant to extend retention of sufferers with opioid use dysfunction (OUD) in outpatient remedy by offering cognitive behavioral remedy, as an adjunct to outpatient remedy that features transmucosal buprenorphine and contingency administration, for sufferers 18 years or older who’re at the moment below the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
Vital Security Data for Clinicians:
Warnings: reSET-O is meant for sufferers whose main language is English with a studying stage of seventh grade or above, and who’ve entry to an Android/iOS pill or smartphone. reSET-O is meant just for sufferers who personal a smartphone and are acquainted with use of smartphone apps (functions). Clinicians shouldn’t use reSET-O to speak with their sufferers about emergency medical points. Sufferers ought to be clearly instructed to not use reSET-O to speak to their clinician any pressing or emergent data. In case of an emergency, sufferers ought to dial 911 or go to the closest emergency room.
reSET-O isn’t meant for use as a stand-alone remedy for Opioid Use Dysfunction (OUD). reSET-O doesn’t exchange care by a licensed medical practitioner and isn’t meant to cut back the frequency or length of in-person remedy. reSET-O doesn’t symbolize a substitution for a affected person’s remedy. Sufferers ought to proceed to take their drugs as directed by their healthcare supplier.
Sufferers with opioid use dysfunction expertise psychological well being illness and co-morbid medical issues at larger charges than the final inhabitants. Sufferers with opioid use dysfunction have larger baseline charges of suicidal ideation, and suicide makes an attempt, and suicide completion. Clinicians ought to undertake normal of care to observe sufferers for medical issues and psychological well being illness, together with threat for harming others and/or themselves.
The long-term advantage of reSET-O has not been evaluated in research lasting past 12 weeks (84 days) within the OUD inhabitants. The flexibility of reSET-O to forestall potential relapse after remedy discontinuation has not been studied.
- Christensen DR, Landes RD, Jackson L, et al. Including an Web-delivered remedy to an efficacious remedy bundle for opioid dependence. J Seek the advice of Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496.
- Yuri A. Maricich, Warren Okay. Bickel, Lisa A. Marsch, Kirstin Gatchalian, Jeffrey Botbyl & Hilary F. Luderer (2020) Security and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for remedy of opioid use dysfunction, Present Medical Analysis and Opinion, DOI: 10.1080/03007995.2020.1846022.