SAN FRANCISCO, Aug. 30, 2017 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) will present clinical data from the
SUMMIT-07 Phase 3 efficacy and safety study of NKTR-181, a
first-in-class opioid analgesic to treat chronic pain, at the
upcoming 2017 PAINWeek® Conference in Las
Vegas, Nevada on September 5-9,
2017. 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.
Clinical data will be presented during a poster presentation
beginning 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. Abstracts may be accessed online
at: http://conference.painweek.org/scientificposters:
- Poster 41: "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 38: "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.
Nektar is also hosting the following educational satellite
presentation at PAINWeek 2017:
- Title: "Analgesic of the Future: A New Opioid Molecule With
Slow Entry Into the CNS"
Speakers: Jeffrey Gudin, MD and Richard Rauck, MD
Wednesday, September 6th
from 12:15 - 1:30 p.m. PDT
Level 3/Castellana Ballroom
PAINWeek is the largest U.S. pain conference for frontline
clinicians with an interest in pain management. The annual
conference presents 120+ hours of continuing medical education
courses and master classes, special interest sessions, and
satellite events geared toward physicians, physician assistants,
nurse practitioners, nurses, pharmacists, hospitalists,
psychologists, and other healthcare professionals involved in pain
management.
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. NKTR-181 is the first opioid
molecule to exhibit reduction in specific CNS-mediated side
effects, like euphoria, through the strategic alteration of
brain-entry kinetics. In addition, NKTR-181 is designed
with an inherent 12-hour elimination half-life to enable
twice-daily dosing with continuous pain control. NKTR-181 is
an investigational medicine and has not been approved by
the FDA or any other regulatory agencies.
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.2
About Nektar Therapeutics
Nektar
Therapeutics is a research-based 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,
autoimmune 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.
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's development in the area of
new pain medicines, the risks of opioid abuse resulting from use of
NKTR-181, as well as from new and existing pain medicines, 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:
Dan Budwick
1AB Media
973.271.6085
- Hyman, Steven E., Harvard Review of Psychiatry. 2(1):43-46,
May/June 1994.
- 2010 Society of Neuroscience Annual Meeting
(Nov 13-17, #HHH11).
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SOURCE Nektar Therapeutics