BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Pear Therapeutics, Inc. today announced that the Health Science Authority (HSA) of Singapore has authorized reSET® for the treatment of adults with substance use disorder (SUD) in that country. This is the first time the HSA has authorized a prescription digital therapeutic (PDT) with claims to treat disease and/or improve clinical outcomes in a disease.
“HSA market authorization reflects our mission to deliver our PDTs worldwide. This first authorization of a PDT outside the U.S. represents an important milestone for Pear and builds on the embrace of PDTs for the treatment of serious diseases like substance use disorder. We look forward to expansion of PDTs to Asia, beginning with providing patients and providers access to reSET in Singapore,” said Corey McCann, M.D., Ph.D., President and CEO of Pear.
reSET, a 12-week (90-day) prescription treatment to be used in conjunction with outpatient clinician-delivered care, will be distributed by local partners to eligible patients in Singapore. reSET offers interactive treatment modules that deliver cognitive behavioral therapy, fluency training to reinforce proficiency, and contingency management. Within a clinician dashboard, clinicians can follow patient-reported substance use, cravings, and triggers to facilitate transparency and encourage deeper interaction between patients and clinicians at face-to-face meetings.
reSET was the first software to receive a label to treat any human disease from FDA. The PDT was studied in a randomized clinical trial that evaluated the therapeutic in 399 patients with SUD across 10 centers in NIDA’s Clinical Trial Network nationwide over 12 weeks of treatment. Patients were randomized to either a standard treatment-as-usual (TAU), which consisted of face-to-face counseling, or to a reduced amount of face-to-face counseling plus the digital therapeutic (PDT+reduced TAU). The clinical study demonstrated that the digital therapeutic more than doubled the rate of abstinence compared to standard, face-to-face counseling (40.3% in PDT+reduced TAU vs 17.6% in TAU, (odds ratio 3.17, (1.68, 5.99) p= 0.0004). In a sub-group analysis of non-abstinent patients at study start, a poor prognostic indicator, patients randomized to the digital therapeutic demonstrated an almost five-fold improvement in abstinence (16.1% in PDT+reduced TAU vs 3.2% in TAU (odds ratio 5.74, (1.99, 16.60) p = 0.0013). Patients randomized to the PDT+reduced TAU also demonstrated an increase in retention in treatment (76.2% in PDT+reduced TAU vs 62.3% in TAU, p = 0.0042).
SUD is a chronic, relapsing disease caused by the recurrent use of alcohol or drugs – or both. According to the National Addictions Management Service (NAMS), alcohol is the number-one addiction and cannabis, heroin, and methamphetamine are the most commonly abused drugs in Singapore. For people with SUD, treatment has typically meant resource-intensive, face-to-face interactions in a specialized setting. Inconsistent quality in treatment, disparities in payment for behavioral health services, and limited accessibility has led to poor treatment outcomes, including low rates of abstinence and high dropout rates.
reSET Important Safety Information
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.
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. reSET is not indicated for patients who abuse alcohol solely.
This Press Release does not include all the information needed to use reSET safely and effectively. Please see the full Clinician Brief Summary for reSET for more information.
About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims 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. Pear has a pipeline of products and product candidates across therapeutic areas. Pear’s lead product, reSET®, for the treatment of Substance Use Disorder, was the first PDT to receive marketing authorization from FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst™ for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.