[December 10, 2018] |
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Sandoz Inc. and Pear Therapeutics Obtain FDA Clearance for reSET-O™ to Treat Opioid Use Disorder
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-O™.
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 carei
and only 13 percent of outpatient facilities in the U.S. offer MAT, such
as buprenorphineii. 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
experienceiii. 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
patientsiv. The finding that reSET-O significantly improved
patient retention rates supports the efficacy of reSET-O in increasing
retention of patients ith OUD in outpatient treatment.
About Opioid Use Disorder Every day, approximately 115
Americans die after overdosing on opioidsv. 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.
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 "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 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.
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 (News - Alert). Sign up to follow
@Sandoz_global at http://twitter.com/Sandoz_Global.
Follow our blog at www.sandoz.com/makingaccesshappen.
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 (News - Alert) 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.
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