-
reSET-OTM is the
first FDA-cleared Prescription Digital Therapeutic (PDT) for
patients with Opioid Use Disorder
-
Pear Therapeutics is leading
the development of a new therapeutic class with two FDA-authorized
PDTs and a robust pipeline of therapeutics across disease
areas
-
Sandoz will lead U.S.
commercial launch, anticipated in coming days in Q4
-
As part of broader Novartis
digital revolution, Sandoz aims to increase patient engagement and
improve access to treatment through digital solutions
HOLZKIRCHEN, December 10,
2018 - Sandoz Inc., a division of Novartis, and Pear
Therapeutics, Inc., the leader in prescription digital
therapeutics, today announced that the U.S. Food and Drug
Administration (FDA) has granted clearance for reSET-OTM.
reSET-O is intended to increase retention of
patients with Opioid Use Disorder (OUD) in outpatient treatment by
providing cognitive behavioral therapy (CBT), as an adjunct to
outpatient treatment that includes transmucosal buprenorphine
(medication-assisted-treatment, or MAT) 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.
"Digital technologies and data science have
incredible potential to unlock the next chapter of medical
innovation and to help individuals finally take control of their
own health in a meaningful way," said Richard Francis, CEO, Sandoz.
"New digital therapeutics such as reSET-O also have the potential
to fundamentally change how patients interact with their therapies
and thus improve patient outcomes. At Sandoz, we are proud to be a
joint pioneer in this exciting new field."
Under the terms of a commercial deal announced in
April 2018, Sandoz will lead marketing and commercialization of
reSET-O and reSET®, Pear's PDT
for the treatment of Substance Use Disorder. Sandoz launched reSET
in November 2018 and plans to launch reSET-O in the coming days in
the U.S.
reSET-O is a 12-week interval PDT for OUD. reSET-O
is modeled on the Community Reinforcement Approach (CRA) and
engineered to deliver CBT for patients with OUD. reSET-O delivers
CRA therapy as a series of interactive therapy lessons. Each
therapy lesson is comprised of a cognitive behavioral therapy
component and skill-building exercises. Therapy lesson content is
delivered primarily via text or audio, and may include videos,
animations, and graphics.
reSET-O is intended as an adjunct to standard of
care for patients with OUD. It is limited to persons with a valid
prescription from their licensed provider. reSET-O supports
clinician-patient communication between visits, by providing a
means for patients to self-report cravings and triggers, and
buprenorphine use/non-use. reSET-O reinforces the importance of
using buprenorphine for treatment of OUD.
"Nearly 50,000 drug overdose deaths involving
opioids, including prescription pain medications and heroin,
took place in the U.S. in 2017," said Corey McCann, M.D., Ph.D.,
President and CEO of Pear Therapeutics. "There is an urgent need
for new and innovative therapeutics to address this public health
epidemic. This groundbreaking decision by the FDA ushers in a new
standard for treating patients with Opioid Use Disorder and it
signals a new path for therapeutic software to be used in
conjunction with pharmacotherapy to improve efficacy."
More than 80 percent of patients with OUD do not
receive or seek out care[i] and only 13 percent of outpatient
facilities in the U.S. offer MAT, such as buprenorphine[ii].
reSET-O could have the potential to dramatically impact this gap in
treatment, by delivering multi-modal therapy in combination with
MAT in a way that is designed to be more effective, convenient, and
easy to access for patients and clinicians. reSET-O helps to offer
standardized and enhanced care for OUD, providing particular
benefit in geographies where access to care is currently
inconsistent or unavailable.
To support the FDA submission of reSET-O, a
National Institute on Drug Abuse-sponsored clinical trial evaluated
the therapeutic in 170 patients with OUD over 12 weeks. Patients
were randomized to receive either treatment-as-usual (TAU), which
consisted of standard clinician interactions in conjunction with
buprenorphine, or reSET-O with standard clinician interactions in
conjunction with buprenorphine. At the end of the study, patients
randomized to reSET-O CBT, when used with outpatient treatment and
contingency management, significantly improved retention among
patients with buprenorphine plus contingency management treatment
experience[iii]. Treatment dropout during the 12-week intervention
was reduced in the test group compared to the TAU group. This
reduction in treatment dropout was significant.
High attrition and relapse rates represent a
significant problem 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 patients[iv]. The finding
that reSET-O significantly improved patient retention rates
supports the efficacy of reSET-O in increasing retention of
patients with OUD in outpatient treatment.
About Opioid Use
Disorder
Every day, approximately 115 Americans die after overdosing on
opioids[v]. 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-OTM Indications
for Use
reSET-OTM 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.
This Press Release does not include all the
information needed to use reSET-O safely and effectively. Please
see the Clinician Brief Summary Instructions for reSET-O for more
information at Clinician Brief Summary Instructions for
reSET-O
About reSET-OTM
The reSET-OTM 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 "pipeline," "to lead," "launch," "anticipated,"
"aims," "will," "groundbreaking," "could," "potential,"
"pioneer," "growing," "may," 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. 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. 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-OTM, 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-OTM and
reSET® are
registered trademarks of Pear Therapeutics, Inc.
References:
[i] Results from the 2013 National Survey on Drug Use and Health:
Summary of National Findings (NSDUH Series H-48, HHS Publication
No. SMA 14-4863). 2014:1-184.
https://store.samhsa.gov/shin/content/SMA16-4892PG/SMA16-4892PG.pdf
[ii] Substance Abuse and Mental Health Services Administration,
National Survey of Substance Abuse Treatment Services (N-SSATS):
2013. Data on Substance Abuse Treatment Facilities. BHSIS Series
S-73, HHS Publication No. (SMA) 14-4890. Rockville, MD: Substance
Abuse and Mental Health Services Administration, 2014.
[iii] https://peartherapeutics.com/reset-o/ or 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.
doi:10.1037/a0037496.
[iv] Weisner C et al. Short-term alcohol and drug treatment
outcomes predict long-term outcome. Drug and Alcohol Dependence.
2003. 71: 281-294.
[v] CDC/NCHS, National Vital Statistics System, Mortality. CDC
Wonder, Atlanta, GA: US Department of Health and Human Services,
CDC; 2017. https://wonder.cdc.gov.
# # #
Novartis Media
Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@novartis.com |
|
Ben Church
Sandoz Global Communications
+49 151 407 41465 (mobile)
benjamin.church@sandoz.com |
Leslie Pott
Sandoz US Communications
+1 609 627 5287
leslie.pott@sandoz.com
|
Novartis Investor
Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central |
|
North
America |
|
Samir
Shah |
+41 61
324 7944 |
Richard
Pulik |
+1 212
830 2448 |
Pierre-Michel Bringer |
+41 61
324 1065 |
Cory
Twining |
+1 212
830 2417 |
Thomas
Hungerbuehler |
+41 61
324 8425 |
|
|
Isabella
Zinck |
+41 61
324 7188 |
|
|
Media release (PDF)