SAN FRANCISCO, Sept. 6, 2017 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today presented clinical data from the
SUMMIT-07 Phase 3 study of NKTR-181, a first-in-class opioid
analgesic to treat chronic pain, at the 2017 PAINWeek®
Conference in Las Vegas taking
place September 5-9. NKTR-181 is a
new chemical entity (NCE) and mu-opioid agonist molecule designed
to provide potent pain relief without the high levels of euphoria
that can lead to abuse and addiction with standard
opioids.1
NKTR-181 is the first analgesic opioid molecule to exhibit
reduction in specific CNS-mediated side effects, like euphoria,
through the strategic alteration of brain-entry
kinetics. The U.S. Food and Drug
Administration (FDA) has granted the investigational medicine
NKTR-181 Fast Track designation for the treatment of moderate to
severe chronic pain.
"The data presented at PAINWeek for SUMMIT-07 show that NKTR-181
represents a major step forward for the treatment of chronic pain
and could be a fundamental building block in the fight against
prescription opioid abuse," said Ivan
Gergel, MD, Senior Vice President and Chief Medical Officer
of Nektar Therapeutics. "Conventional opioid analgesics can produce
withdrawal symptoms after cessation of chronic administration,
which can lead to drug craving and opioid misuse. The
withdrawal measurements taken throughout the efficacy trial of
NKTR-181 show that 98 percent or more of patients in the study
experienced no opioid withdrawal either during or after treatment
with NKTR-181. The totality of our efficacy and safety data show
that NKTR-181 provides strong analgesia in patients suffering from
chronic pain without fear of serious safety concerns or the
potential for abuse and addiction of conventional opioids. We are
highly committed to bringing this critical new medicine to patients
and physicians as quickly as possible."
Pain is one of the most common reasons people seek medical
treatment.2 Low back pain is the second most common
cause of disability for adults in
the U.S. 3 Approximately 149 million work
days are lost every year because of low back pain, with total costs
estimated to be $100 to 200 billion a year (of which
two-thirds is due to lost wages and lower
productivity).4 A study published in
the American Pain Society's The Journal of
Pain in October 2014 estimated that 19 percent of
the U.S. population, or 39 million people, suffer from
some type of persistent pain.5
The poster session presented at PAINWeek began Wednesday,
September 6th at 3:00 p.m. Pacific Daylight
Time. Authors will be available at the Scientific Session
reception on Thursday, September 7th
from 6:30 - 8:30 p.m. PDT.
Links to the poster presentations at PAINWeek® are
below:
Poster Number: 41
Title: Efficacy, safety, and tolerability of NKTR-181 in
patients with moderate to severe chronic low-back pain: A Phase 3
study, Markman J, et al.
Poster Number: 38
Title: Measuring withdrawal in a phase 3 study of a new
analgesic, NKTR-181, in subjects with moderate to severe chronic
low-back pain, Henningfield, J., et al.
Opioid analgesics are commonly used in the treatment of chronic
pain; however, their use is limited by poor tolerability and a high
prevalence of abuse and drug-related mortality.6-8.
NKTR-181 was designed to have a reduced rate of entry into the
central nervous system (CNS) compared with standard opioids,
thereby reducing a key pharmacokinetic risk factor related to
potential for euphoria and abuse.9
About Nektar
Nektar Therapeutics is a
research-based development stage biopharmaceutical company whose
mission is to discover and develop innovative medicines to address
the unmet medical needs of patients. Our R&D pipeline of new
investigational medicines includes treatments for cancer,
auto-immune disease and chronic pain. We leverage Nektar's
proprietary and proven chemistry platform in the discovery and
design of our new therapeutic candidates. Nektar is headquartered
in San Francisco, California, with additional operations
in Huntsville, Alabama and Hyderabad, India.
Further information about the company and its drug development
programs and capabilities may be found online
at http://www.nektar.com.
About NKTR-181
NKTR-181 is the first
long-acting, selective mu-opioid agonist designed to provide potent
pain relief without the inherent high levels of euphoria which lead
to abuse and addiction with standard opioids. The novel
molecular structure of NKTR-181 is designed to have low
permeability across the blood-brain barrier in order to slow its
rate of entry into the brain and attenuate the dopamine release
that underlies euphoria. In addition, NKTR-181 is designed with an
inherent 12-hour elimination half-life to enable twice-daily dosing
with continuous pain control.
Current and past strategies of abuse deterrence to address the
addictive qualities of standard opioids rely on formulations
alone. However, all abuse-deterrent formulations are
pre-cursors to highly euphorigenic rapid-acting opioids, which can
be liberated through tampering. The National Survey on Drug
Use and Health (NSDUH) indicated that 16.0 million people in the
U.S. reported using oxycodone products non-medically in their
lifetime in 2012.
Preclinical and clinical data show that the inherent properties
of NKTR-181 reduce its rate of entry into the brain compared to
standard mu opioids, regardless of route of
administration.10
The U.S. Food and Drug Administration (FDA) has granted the
investigational medicine NKTR-181 Fast Track designation for the
treatment of moderate to severe chronic pain. NKTR-181 is an
investigational medicine and has not been approved by the FDA or
any other regulatory agencies.
PAINWeek® is a registered trademark
of painweek.org.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which can
be identified by words such as: "plan," "expect," "may," "will,"
"believe," "can," "should," "could" and similar references to
future periods. Examples of forward-looking statements include,
among others, statements we make regarding the potential
therapeutic benefit of NKTR-181 for treating patients with pain,
the potential importance of NKTR-181 in addressing opioid abuse,
the risks of opioid abuse resulting from use of NKTR-181, and
certain other statements regarding the prospects and potential of
NKTR-181 specifically, and Nektar's business and technology
platform generally. Forward-looking statements are neither
historical facts nor assurances of future performance. Instead,
they are based only on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and
strategies, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Our actual results may differ
materially from those indicated in the forward-looking statements.
Therefore, you should not rely on any of these forward-looking
statements. Important factors that could cause our actual results
to differ materially from those indicated in the forward-looking
statements include, among others: (i) challenges and uncertainties
inherent in pharmaceutical research and development, including the
uncertainty of future clinical and regulatory success, where the
risk of failure remains high and failure can unexpectedly occur at
any stage prior to regulatory approval due to lack of sufficient
efficacy, safety considerations or other factors; (ii) the
regulatory pathway to review and approve NKTR-181 for use in
patients, even with a Fast Track designation by the FDA, is
subject to substantial uncertainty; (iii) regulations concerning
and controlling the access to opioid-based pharmaceuticals are
strict and there is no guarantee which scheduling category will
apply to NKTR-181 if regulatory approval is achieved; (iv) drug
manufacturing challenges which can delay or render unavailable
sufficient supplies of NKTR-181; (v) changing standards of care and
new regulations (including, but not limited to, standards and
regulations related to health care cost containment) can affect the
use NKTR-181 and commercial success following a regulatory
approval; (vi) Nektar's patent applications for NKTR-181 may not
issue in one or more jurisdictions, patents that have issued may
not be enforceable, or additional intellectual property licenses
from third parties may be required in the future; (vii) the outcome
of any existing or future intellectual property or other litigation
related to Nektar's proprietary product candidates, including,
without limitation, NKTR-181, is unpredictable and could have a
material adverse effect on our business; and (viii) certain other
important risks and uncertainties set forth in Nektar's Quarterly
Report on Form 10-Q for the quarter ended June 30,
2017 filed with the Securities and Exchange
Commission on August 9, 2017. Any forward-looking
statement made by us in this press release is based only on
information currently available to us and speaks only as of the
date on which it is made. We undertake no obligation to update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Contact:
For Investors:
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
Jodi Sievers of Nektar
Therapeutics
415-482-5593
For Media:
Jennifer Paganelli
347-658-8290
jpaganelli@purecommunications.com
- Melnikova, I, Pain Market, Nature Reviews Drug Discovery,
Volume 9, 589-90 (August 2010).
- 2011 National Academy of Sciences. Relieving Pain in America: A
Blueprint for Transforming Prevention, Care, Education and
Research, 2010 Decision Resources, and Harstall, C. How prevalent
is chronic pain? Pain Clinical Updates X, 1-4 (2003).
- Arch Intern Med 2009 February 9;
169(3): 251-258.
- World Health Organization: Priority Medicines for Europe and the World Update Report, 2013;
Background Paper 6.24, Low Back Pain.
-
http://americanpainsociety.org/about-us/press-room/persistent-pain-incidence-news-release.
- Ballantyne JC. Assessing the prevalence of opioid misuse,
abuse, and addiction in chronic pain. Pain.
2015;156(4):567–568.
- Centers for Disease Control and Prevention (CDC). Increases in
drug and opioid overdose deaths—United States, 2000–2014.
MMWR. 2016;64(50):1378–1382.
- Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina
I, et al. The effectiveness and risks of long-term opioid therapy
for chronic pain: a systematic review for a National Institutes of
Health Pathways to Prevention Workshop. Ann Intern Med.
2015;162(4):276–286.
- Miyazaki T, et al., J Pharmacol Exp Ther. 2017.
doi:10.1124/jpet.117.243030.
- 2010 Society of Neuroscience Annual Meeting (Nov 13-17, #HHH11).
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SOURCE Nektar Therapeutics