Medtronic Enrolls First Patient in Clinical Study to Assess Pain Control and Oral Opioid Elimination with Targeted Drug Deliv...
January 17 2019 - 9:00AM
Study Will Further
Advance Understanding of Effectiveness and Tolerability of the
SynchroMed(TM) II Intrathecal Drug Delivery System in Patients Who
Have Weaned off Oral Opioids
DUBLIN - January 17, 2019 -
Medtronic plc (NYSE:MDT) today announced the first patient enrolled
in the Embrace TDD (targeted drug delivery) clinical study that
will evaluate the use of the SynchroMed(TM) II intrathecal drug
delivery system ("Medtronic pain pump") as an alternative to oral
opioids for patients with chronic intractable non-malignant primary
back pain with or without leg pain. The Medtronic pain pump
provides effective pain relief at a fraction of the oral dose with
fewer side effects and may help reduce or eliminate the use of oral
opioids.1-7 The Embrace
TDD study will follow patients who wean completely from all oral
opioids and have a successful intrathecal drug trial. The first
patient was enrolled by John A. Hatheway, M.D., in Spokane,
Wash.
Oral opioids are widely used to treat pain;
however, there is limited evidence on the effectiveness and
benefits of long-term oral opioid therapy.8 Given the
current opioid epidemic and ongoing pain management crisis, there
is a need to better understand solutions that effectively address
chronic pain and support the elimination of oral opioids. There is
evidence that oral opioid tapering and elimination may improve pain
relief and allow for treatment with a lower effective dose of
intrathecal medication compared to a combination of oral and
intrathecal treatment.6 The Embrace
TDD study was designed to further understand the impact of an
opioid-free period prior to TDD treatment on patient outcomes.
"There are several strategies to approach weaning
prior to or following TDD treatment. The Embrace TDD study is
important because it will evaluate the impact of weaning patients
completely off oral opioids before treating them with intrathecal
therapy using the Medtronic pain pump," said John A. Hatheway,
M.D., owner and provider, Northwest Pain Care, Spokane, Wash. "My
goal is to provide patients with effective pain relief and help
them eliminate long-term oral opioid use. Understanding the effect
of being opioid free prior to TDD treatment may be clinically
relevant as clinicians seek to optimize the use of long-term
alternatives to oral opioids."
The Embrace TDD study is a prospective,
multi-center, post-market study that will enroll approximately 100
patients with chronic intractable non-malignant primary back pain
with or without leg pain at up to 15 sites in the U.S. Patients
will wean from all oral opioids prior to initiating intrathecal
therapy. The study will assess pain control and opioid-related side
effects at six months following a route of delivery change to
intrathecal preservative-free morphine sulfate. Patients taking a
daily systemic opioid dose of <= 120 Morphine Milligram
Equivalents (MME), who are candidates for TDD, are eligible.
Patients will be followed for 12 months. More details can be found
at ClinicalTrials.gov.
"As part of our commitment to helping address the
opioid crisis, Medtronic is investing in clinical research and
tools that can increase understanding of how to use proven
alternative treatments, like TDD, for patients with uncontrolled
chronic pain," said Charlie Covert, vice president and general
manager, Targeted Drug Delivery, Medtronic Pain Therapies. "We hope
the Embrace TDD study will provide valuable insights about how to
best optimize use of the Medtronic pain pump and enable clinicians
to help more patients with chronic pain, which has a significant
personal and societal impact."
The Medtronic pain pump and catheter are implanted
under the skin and deliver medication into the intrathecal space,
enabling clinicians to prescribe reduced doses compared to
systemically delivered medications and tailor drug delivery to
patient needs. Medtronic recently launched the Control
WorkflowSM, an
evidence-based approach for use with the Medtronic pain pump that
helps physicians wean patients off oral opioids and assists them in
identifying patients likely to have positive outcomes with the
Medtronic pain pump. It was developed by clinicians and provides
comprehensive guidance on therapy initiation, catheter placement,
and dosing that could impact successful outcomes with the goal of
sustained pain relief and functional improvement.1,6
About Chronic Pain
Chronic pain, which lasts more than three to six months, is a
disabling condition that adversely affects wellbeing and can
interfere with working, sleeping, and participating in physical
activities, ultimately affecting quality of life. At least 100
million American adults - more than those affected by heart
disease, cancer, and diabetes combined - are affected by chronic
pain.9 It is
estimated that the cost to treat chronic pain in the U.S., as well
as related lost productivity, is as high as $635 billion
annually.10
About Medtronic Pain
Therapies
Medtronic has more than a 40-year history of developing innovative
medical devices that have been shown to alleviate pain in different
disease states and has a broad portfolio of device-delivered
therapies that are alternatives or adjuncts to oral
opioids.3 Medtronic
strives to be at the forefront of medical device innovation and to
develop high-quality pain therapies that reduce pain and improve
quality of life. While Medtronic pain therapies do not treat opioid
addiction, we are committed to leveraging our capabilities and
product portfolio in partnership with stakeholders - patients,
providers, payers, regulators, elected officials, patient advocacy
groups and employers - to address the unmet needs of pain patients
and to support efforts to prevent opioid misuse due to chronic
intractable pain.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services,
and solutions companies - alleviating pain, restoring health, and
extending life for millions of people around the world. Medtronic
employs more than 86,000 people worldwide, serving physicians,
hospitals, and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
References
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Hamza M, Doleys D, Wells M, et al. Prospective
study of 3-year follow-up of low-dose intrathecal opioids in the
management of chronic nonmalignant pain. Pain
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Smith TJ, Staats PS, Deer T, et al. Randomized
clinical trial of an implantable drug delivery system compared with
comprehensive medical management for refractory cancer pain: impact
on pain, drug-related toxicity, and survival. Journal of clinical oncology: official journal of the
American Society of Clinical Oncology.
2002;20(19):4040-4049.
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Deer T, Chapple I, Classen A, et al. Intrathecal
drug delivery for treatment of chronic low back pain: report from
the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5(1): 6-13.
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Atli A, Theodore BR, Turk DC, Loeser JD.
Intrathecal opioid therapy for chronic nonmalignant pain: a
retrospective cohort study with 3-year follow-up. Pain Med. 2010;11(7):1010-1016.
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Hatheway JA, Caraway D, David G, et al. Oral
opioid elimination after implantation of an intrathecal drug
delivery system significantly reduced health-care expenditures.
Neuromodulation : journal of the International Neuromodulation
Society. 2015;18(3):207-213.
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Grider JS, Etscheidt MA, Harned ME, et al.
Trialing and maintenance dosing using a low-dose intrathecal opioid
method for chronic nonmalignant pain: a prospective 36-month study.
Neuromodulation : journal of the International
Neuromodulation Society. 2016;19(2):206-219.
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Onofrio BM, Yaksh TL. Long-term pain relief
produced by intrathecal morphine infusion in 53 patients. J Neurosurg. 1990;72(2):200-209.
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Chou R, Deyo RA, Devine B, et al. The effectiveness and risks of long-term opioid treatment
of chronic pain: evidence report/technology assessment No. 218.
AHRQ publication no. 14-E005- EF. Rockville, MD: Agency for
Healthcare Research and Quality; 2014.
-
Institute of Medicine.
Relieving pain in America: a blueprint for transforming prevention,
care, education, and research. Washington DC, United States:
The National Academies Press; 2011.
-
Darrell J. Gaskin, Patrick Richard. The Economic
Costs of Pain in the United States. The
Journal of Pain, 2012; 13 (8): 715
DOI: 10.1016/j.jpain.2012.03.009
Contacts:
Michelle Claypool
Public Relations
+1-763-526-9452
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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: Medtronic plc via Globenewswire
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