||| Menü 
Firmenveranstaltungen, Neuemissionen

Geschäftsberichte, Werbung, Earnings, Marketing, Verordnungen

Fusionen, Übernahmen

Personal, Belegschaft, Meldungen zu Produkten


Bankleitzahlen - online.de

Sandoz and Pear Therapeutics Announce US Launch of reSET-OTM to Help Treat Opioid Use Disorder

Novartis International AG /
Sandoz and Pear Therapeutics Announce US Launch of reSET-OTM to Help Treat
Opioid Use Disorder
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.

* reSET-O(TM)* is the first US FDA-cleared prescription digital therapeutic
for patients with Opioid Use Disorder
* Cleared by the FDA in December, reSET-O is available immediately
* As part of a broader focus on digital healthcare solutions at Novartis,
Sandoz aims to increase patient engagement and improve access to treatment
through digital solutions

HOLZKIRCHEN, January 7, 2018 - Sandoz Inc., a Novartis division, and Pear
Therapeutics, Inc., announced today the US commercial launch of reSET-O(TM) 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 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 patients(i). 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 opioids(ii). 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

reSET-O(TM) Indications for Use
reSET-O(TM) 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(TM)
The reSET-O(TM) 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.

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(TM), 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((TM)) and reSET(®) are registered trademarks of Pear Therapeutics,

   [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.

# # #

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)

Chris Lewis Leslie Pott
Sandoz Global Communications Sandoz US Communications
+49 174 244 9501 (mobile) +1 609 627 5287
chris.lewis@sandoz.com 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):

This announcement is distributed by West Corporation on behalf of West Corporation clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Novartis International AG via GlobeNewswire

 ||| Themen-Infos 
· Mehr zu dem Thema Allgemeine Nachrichten

Der meistgelesene Artikel zu dem Thema Allgemeine Nachrichten:
FDA expands age indication for Menveo®, first and only quadrivalent meningococcal vaccine for infants as young as 2 months of age[1]

 ||| Artikel Bewertung 
durchschnittliche Punktzahl: 0
Stimmen: 0

Bitte nehmen Sie sich einen Augenblick Zeit, diesen Artikel zu bewerten:

Sehr gut

Web site engine's code is Copyright © 2003 by PHP-Nuke. All Rights Reserved. PHP-Nuke is Free Software released under the GNU/GPL license.
Erstellung der Seite: 0.077 Sekunden