- reSET® is the first and only FDA-authorized prescription
digital therapeutic for Substance Use Disorder (SUD)
- Adding reSET to outpatient therapy significantly improved
abstinence in substances of abuse and treatment retention compared
to standard of care alone
- Sandoz and Novartis continue to embrace digital technologies to
enhance R&D and deliver better outcomes for patients
Holzkirchen, November 19, 2018 - Sandoz, a
Novartis division, and Pear Therapeutics, Inc., announced today the
commercial launch of reSET® for patients with Substance Use
Disorder (SUD). reSET, the first and only FDA-authorized
prescription digital therapeutic, is immediately available.
Study results from a multicenter, randomized clinical trial
showed that reSET, when used with outpatient therapy and
contingency management, significantly improved abstinence in
substances of abuse and increased retention as compared to
outpatient therapy alone. The reSET therapeutic content was
validated in a randomized clinical trial through the National
Institute of Drug Abuse (NIDA) Clinical Trial Network.
reSET is a 12-week (90-day) prescription digital therapeutic to
be used in conjunction with outpatient clinician-delivered care.
reSET offers interactive treatment modules that deliver cognitive
behavioral therapy and fluency training to reinforce proficiency.
Within the clinician dashboard, clinicians can follow
patient-reported substance use, cravings, and triggers to
facilitate transparency and deeper interaction between patients and
clinicians at face-to-face meetings.
"We all have a role to play in helping find solutions that work
for patients, families and communities as we fight the substance
abuse epidemic," said Richard Francis, CEO, Sandoz. "Adding reSET
to outpatient therapy enhances behaviors associated with recovery.
It leverages new technology to help patients improve abstinence in
substances of abuse and stay in treatment programs longer than
outpatient therapy alone."
"Patients with Substance Use Disorder deserve access to more
effective, convenient, and innovative treatment options," said
Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics.
"reSET has been clinically validated to significantly improve
outcomes for patients, while also providing patients a discreet way
to access care when and where they need it. Prescription digital
therapeutics will help redefine the treatment of serious diseases
like Substance Use Disorder, providing improved patient outcomes,
and driving clinical insights for clinicians."
To support patients and clinicians, Pear Therapeutics has also
launched the reSET ConnectTM Patient Service Center. A specialist
is available to provide access to reSET, walk patients and
clinicians through the steps for downloading and using reSET,
troubleshoot any issues with reSET, and work with the patient's
insurance company to ensure a seamless treatment experience.
In April, Sandoz entered into a collaboration with Pear
Therapeutics, Inc. to commercialize and continue development of
reSET - designed to effectively augment clinicians and improve
clinical outcomes for patients. The collaboration brought together
Sandoz expertise in launching and commercializing treatments with
Pear's leading experience in prescription digital therapeutics
design, development, and implementation.
SUD is a chronic, relapsing disease caused by the recurrent use
of alcohol or drugs - or both. 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.
This collaboration is part of the Sandoz and Novartis strategic
effort to work with innovative digital health leaders to drive the
next wave of medical innovation. Sandoz and Novartis are
collaborating to develop technologies to monitor patient data in
real-time, detect day-to-day behavioral and biological changes in
condition, improve patient adherence, and ultimately enhance
treatment outcomes by helping patients to take a more active role
in their own healthcare.
Pear is a leader in developing prescription digital
therapeutics, developing the first FDA-authorized prescription
digital mobile medical application with both a safety and
effectiveness label to help treat patients with SUD.
For more information about reSET, go to
www.resetforrecovery.com. To help patients get started with reSET,
call 1-833-MY RESET (1-833-697-3738) Monday-Friday, 8am-6pm ET or
go to www.resetconnect.com.
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 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 replace care by a licensed medical practitioner. reSET does not
represent a substitution for a patient's medication. Patients
should continue to take their medications as directed by their
healthcare provider.
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.
This Press Release does not include all the information needed
to use reSET safely and effectively. Please see the full reSET
Clinician Directions for Use within the reSET Clinician Dashboard
for complete Important Safety Information at
https://www.resetforrecovery.com/pdf/reSET%20Brief%20Summary%20Instructions%20Clinician%20Information.pdf
DisclaimerThis 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 "to
develop," "potential," "pending," "growing," "strategy," "aim,"
"may," "will," "investigational," "launching," "strategic
effort," "next wave," or similar terms, or by express or
implied discussions regarding potential launches, marketing
clearances, new indications or labeling for 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. You should not place undue
reliance on these statements. 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. 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. Nor can there be any guarantee that 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.
* reSET® and reSET ConnectTM are registered trademarks of Pear
Therapeutics, Inc.
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.
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 mental health disorders, severe
insomnia, and multiple sclerosis. Our lead product,
reSET®, treats Substance Use Disorder (SUD), and was the
first prescription digital therapeutic to receive marketing
authorization from the FDA to treat disease. Pear's
second product, reSET-OTM, for the treatment of Opioid Use Disorder
(OUD), is currently under FDA review with Breakthrough Designation.
For more information, visit us
at www.peartherapeutics.com.
###
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RelationsCentral media line: +41 61 324
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Novartis Global
Media RelationsEric Althoff+41 61 324
7999eric.althoff@novartis.com |
Sandoz US
Communications Leslie Pott +1 609 627
5287leslie.pott@sandoz.com |
Sandoz Global
CommunicationsChris Lewis+49 8024 476
1906chris.lewis@sandoz.com |
Novartis Investor RelationsCentral investor relations
line: +41 61 324 7944E-mail: investor.relations@novartis.com
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Pear Therapeutics Amanda Galgay Pear Therapeutics
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