SAN FRANCISCO, June 14, 2018 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today announced that new clinical and
preclinical data for NKTR-181 were presented this week at the 80th
Annual Scientific Meeting of the College on Problems of Drug
Dependence (CPDD) in San Diego,
California. NKTR-181 is a new molecular entity (NME) and the
first analgesic opioid molecule to exhibit a reduced incidence of
specific CNS-mediated side effects, such as euphoria, through the
targeted alteration of brain-entry kinetics.
"We are privileged that these meaningful new data from our
clinical trials, as well as our translational research, were
recognized for oral presentation at the prestigious CPDD meeting,"
said Steve Doberstein, Ph.D., Senior
Vice President and Chief Research and Development Officer of Nektar
Therapeutics. "The data presented show that NKTR-181 demonstrates
consistently low abuse potential when we look at a range of
measurements used to understand potential abuse liability of
investigational medicines including the MADDERS assessment. In
addition, we demonstrated in our preclinical research that NKTR-181
has a unique neuropharmacodynamic profile with slow brain uptake
and a blunted dopamine response as compared to oxycodone."
The full presentations made at CPDD can be found at the links
below:
College on Problems of Drug Dependence 80th Annual Scientific
Meeting (2018), San Diego,
CA
- Oral Presentation: "Assessment of Drug Abuse-Related
Events with MADDERS in SUMMIT-07: A Phase-3 Study of NKTR-181 in
Patients with Moderate to Severe Chronic Low-Back Pain"
-
- Abstract #76
- Presenter: Ryan Lanier,
Ph.D., Analgesic Solutions
- Session: The Pain and the Strain Comes Mainly from the
Brain
- Date/Time: Wednesday, June
13 at 1:30 pm-1:45 pm Pacific
Time
- Oral Presentation: "Neuropharmacodynamic Profile of
NKTR-181: Correlation to Low Abuse Potential"
-
- Abstract #335
- Presenter: Laurie
Vanderveen, Ph.D., Nektar Therapeutics
- Session: Basically Opioids
- Date/Time: Tuesday, June
12 at 10:15 am-10:30 am Pacific
Time
- Poster Presentation: "NKTR-181 demonstrates low abuse
potential in recreational opioid users in two double-blind,
randomized crossover human abuse potential studies",
Henningfield, J., et al.
-
- Abstract #168
- Session: Abuse Liability
- Date/Time: Thursday, June 14 at 12:00 pm- 2:00 pm Pacific Time
There is wide variation across opioids with respect to
nonmedical use, abuse, and associated overdose deaths, with the
highest rates of nonmedical use and overdose occurring with those
that produce euphoric effects. In 2014, nearly 2 million Americans
either abused or were dependent on prescription opioid pain
relievers.1
Nektar recently submitted a New Drug Application for NKTR-181
for the treatment of chronic low back pain in adult patients new to
opioid therapy. The NDA is supported by an extensive clinical
and nonclinical data package. The clinical data submitted in the
NDA comprised 15 studies in 2,234 subjects and includes: a
600-patient efficacy study in patients with chronic low back pain
who are new to opioid therapy; a 630-patient long-term 52-week
safety study in patients with noncancer pain, who are new to
opioid therapy, as well as those who are experienced with opioid
therapy; pharmacokinetic/pharmacodynamic studies in over 450
subjects; and two human abuse potential studies evaluating both
therapeutic and supratherapeutic doses of NKTR-181 versus an
oxycodone control in recreational drug users.
About Chronic Low Back Pain
Low back pain is the second most common cause of disability for
adults in the U.S.2 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).3
About NKTR-181
NKTR-181 is the first long-acting, selective full 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 has a
14-hour elimination half-life to enable twice-daily dosing for pain
control.
Current and past strategies of abuse deterrence to address the
addictive properties of standard opioids rely on formulations
alone. However, all abuse-deterrent formulations are
precursors to highly euphorigenic rapid-acting opioids, which can
be liberated through tampering.
NKTR-181 is not a prodrug, a reformulation, or a drug product
formulated for sustained release of an existing opioid. Nonclinical
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.4 NKTR-181 is an investigational
medicine and has not been approved by the FDA or any
other regulatory agencies.
About Nektar Therapeutics
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.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which
can be identified by words such as: "design," "exhibit," "address,"
"can" 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. 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 regulatory
success, where the risk of failure remains high and failure can
unexpectedly occur 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 both in the United States and in equivalent foreign
regulatory agencies; (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 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
filed with the Securities and Exchange Commission on May 10, 2018. 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 of 1AB
973-271-6085
dan@1abmedia.com
1. Substance Abuse and Mental Health Services
Administration, National Survey on Drug Use and Health, 2014.
2. Arch Intern Med 2009 February 9; 169(3): 251-258.
3. World Health Organization: Priority Medicines for
Europe and the World Update
Report, 2013; Background Paper 6.24, Low Back Pain.
4. 2010 Society of Neuroscience Annual Meeting
(Nov 13-17, #HHH11)
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SOURCE Nektar Therapeutics