BOSTON--(BUSINESS WIRE)--Sandoz Inc., a Novartis division, and Pear Therapeutics, Inc., announced today the US commercial launch of reSET-O™ for patients with Opioid Use Disorder (OUD). reSET-O, cleared by the US Food and Drug Administration (FDA) in December, is immediately available.
The reSET-O prescription digital therapeutic (PDT) is a 12-week cognitive behavioral therapy intended to be used in addition to outpatient treatment. It includes transmucosal buprenorphine, a commonly used medication to treat opioid addiction, and contingency management designed to provide incentives to reinforce positive behaviors. reSET-O is available by prescription only for patients 18 years or older under the care of a clinician.
“The launch of reSET-O provides an important technology-based treatment option for patients with Opioid Use Disorder and may fundamentally change how they interact with their therapies,” said Richard Francis, CEO, Sandoz. “At Sandoz, we are proud and excited to push the frontiers of medical innovation.”
“Addiction is a chronic and relapsing disease that requires constant support, monitoring and access to treatment,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “We believe prescription digital therapeutics can transform the way clinicians treat addiction by providing a way for patients to access treatment when and where it’s needed. reSET-O has been clinically proven to increase the likelihood that a patient will remain in treatment, while also providing a way for patients to access treatment anytime, anywhere, under clinician supervision.”
The efficacy of reSET-O was evaluated in a pivotal, randomized trial of 170 patients seeking treatment for OUD, who received supervised buprenorphine treatment paired with a behavior therapy program, either with or without the addition of the Therapeutic Education System (TES), which had equivalent content to reSET-O. The clinical trial showed that reSET-O therapeutic content had an overall retention rate of 82.4 percent through the end of 12 weeks of treatment compared with 68.4 percent overall retention rate for patients who did not use reSET-O.
reSET-O also serves as a training, monitoring and reminder tool for healthcare providers by leveraging the Clinician Dashboard. The dashboard helps clinicians gain deeper insights into their patients’ progress toward recovery, including patient-reported buprenorphine adherence to allow for more transparency during in-person therapy sessions.
When a healthcare provider prescribes reSET-O, the patient is contacted by a patient care specialist and is provided with an access code. The patient then downloads and installs reSET-O on their smartphone or tablet and enters the access code to unlock treatment. After that, the patient can begin working and learning with reSET-O by completing lessons, answering quiz questions, reporting medication usage and reporting substance use, cravings and triggers. All the while, the patient continues to see the clinician in therapy sessions and progress on reSET-O is tracked via the Clinician Dashboard.
Under the terms of a commercial deal announced in April 2018, Sandoz will lead marketing and commercialization of reSET-O and reSET®*, Pear’s prescription digital therapeutics for the treatment of Substance Use Disorder and Opioid Use Disorder, respectively. Sandoz launched reSET in November 2018 and now has made reSET-O available to patients in the U.S.
High attrition and relapse rates represent a significant obstacle to providing care to patients with OUD. Therefore, it is important to retain patients in treatment. Retention in treatment is a well-established indicator of successful treatment outcomes for OUD patientsi. The study data demonstrate that reSET-O significantly improved OUD patient retention rates in outpatient treatment.
For more information about reSET-O, go to www.resetforrecovery.com. To help patients get started with reSET-O, call 1-833-MY-RESET (1-833-697-3738) Monday-Friday, 8am-6pm ET or go to www.resetconnect.com.
About Opioid Use Disorder
Every day, approximately 115
Americans die after overdosing on opioidsii. The misuse of
and addiction to opioids—including prescription pain relievers, heroin,
and synthetic opioids—is a serious national crisis that affects public
health as well as social and economic welfare. The Centers for Disease
Control and Prevention estimates that the total “economic burden” of
prescription opioid misuse alone in the United States is $78.5 billion a
year, including the costs of healthcare, lost productivity, addiction
treatment, and criminal justice involvement.
reSET-O™ 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 Mobile Medical Application.
Limitation for Use:
reSET-O has not been shown to decrease illicit
drug use or improve abstinence in patients with OUD.
This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the full Clinician Brief Summary Instructions for reSET-O for more information.
About reSET-O™
The reSET-O™ prescription mobile medical
application is a 12-week (84-day) software application. It is limited to
persons with a valid prescription from their licensed provider. reSET-O
is intended to be used to increase retention of patients with Opioid Use
Disorder in outpatient treatment by providing cognitive behavioral
therapy, as an adjunct to outpatient treatment that includes
transmucosal buprenorphine and contingency management to patients
currently under clinician care.
Disclaimer
This press release contains forward-looking
statements within the meaning of the United States Private Securities
Litigation Reform Act of 1995. Forward-looking statements can generally
be identified by words such as “launch,” “aims,” “will,” “may,”
“believe,” “can,” “could,” “potential,” “pioneering,” “growing,” or
similar terms, or by express or implied discussions regarding potential
launches, marketing clearances and authorizations, new indications or
labeling for reSET-O, reSET, or the other products described in this
press release, or regarding potential future revenues from such products
or the collaboration with and investment in Pear Therapeutics. Such
forward-looking statements are based on our current beliefs and
expectations regarding future events, and are subject to significant
known and unknown risks and uncertainties. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those set forth
in the forward-looking statements. You should not place undue reliance
on these statements. There is no guarantee that the collaboration with
and investment in Pear Therapeutics will achieve any or all of its
intended goals and objectives, or be commercially successful. Neither
can there be any guarantee that reSET-O will be successfully launched in
the U.S., in the expected time frame, or at all. Nor can there be any
guarantee that reSET-O, reSET or the other products described in this
press release will be commercially successful in the future. In
particular, our expectations regarding such products, and the
collaboration with and investment in Pear Therapeutics, could be
affected by, among other things, the uncertainties inherent in research
and development, including clinical trial results and additional
analysis of existing clinical data; regulatory actions or delays or
government regulation generally; global trends toward health care cost
containment, including government, payor and general public pricing and
reimbursement pressures; the particular prescribing preferences of
physicians and patients; competition in general, including potential
approval of additional competing versions of such products; our ability
to obtain or maintain proprietary intellectual property protection;
litigation outcomes, including intellectual property disputes or other
legal efforts to prevent or limit Sandoz or Pear Therapeutics from
marketing its products; general political, economic and industry
conditions; safety, quality or production issues; potential or actual
data security and data privacy breaches, or disruptions of our
information technology systems, and other risks and factors referred to
in Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update
any forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
About Sandoz
Sandoz is a global leader in generic
pharmaceuticals and biosimilars. As a division of the Novartis Group,
our purpose is to discover new ways to improve and extend people’s
lives. We contribute to society’s ability to support growing healthcare
needs by pioneering novel approaches to help people around the world
access high-quality medicine. Our portfolio of approximately 1000
molecules, covering all major therapeutic areas, accounted for 2017
sales of USD 10.1 billion. In 2017, our products reached well over 500
million patients. Sandoz is headquartered in Holzkirchen, in Germany’s
Greater Munich area. Sandoz is on Twitter. Sign up to follow
@Sandoz_global at http://twitter.com/Sandoz_Global.
Follow our blog at www.sandoz.com/makingaccesshappen.
About Pear Therapeutics
Pear Therapeutics is the
leader in prescription digital therapeutics. We aim 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, including severe psychiatric and
neurological conditions. Our lead product, reSET®, treats Substance
Use Disorder and was the first prescription digital therapeutic to
receive marketing authorization from the FDA to treat disease. Pear’s
second product, reSET-O™, for the treatment of Opioid Use Disorder,
received marketing clearance from the FDA in December 2018. For more
information, visit us at www.peartherapeutics.com.
* reSET-O™ and reSET® are registered trademarks of Pear Therapeutics, Inc.
References:
i. Weisner C et al. Short-term alcohol and drug treatment outcomes predict long-term outcome. Drug and Alcohol Dependence. 2003. 71: 281-294.
ii. CDC/NCHS, National Vital Statistics System, Mortality. CDC Wonder, Atlanta, GA: US Department of Health and Human Services, CDC; 2017. https://wonder.cdc.gov
