Following the titration period, patients were randomized 1:1 to either continue to receive their analgesic dose of NKTR-181 or to receive placebo for 21 days. NKTR-181 performed as expected as an opioid analgesic throughout the study with patients continuing to show a reduction in pain scores throughout the randomized phase of the study as well. However, patients who were randomized to placebo did not show the expected increase in pain scores observed in similar enriched enrollment, randomized withdrawal studies. This unusual lack of a placebo rebound caused the Phase 2 study to miss the primary endpoint in the study, which was based upon the average change in a patient's pain score from pre-randomization baseline to the end of the double-blind, randomized treatment period of the study.
"We are experiencing a major public health problem with prescription opioids in this country, and need to find new ways to address this problem," said Dr.
NKTR-181 was also well-tolerated over the entire treatment period. The most common adverse events observed for patients taking NKTR-181 were constipation (22.4%) and nausea (10.3%). Discontinuation for adverse events was 18% during the titration period with the most common adverse events cited for discontinuation of constipation (8.8%), nausea (4%) and somnolence (3%).
"The results from this Phase 2 trial provide a great deal of additional insight into the analgesic profile of NKTR-181 and will be invaluable as we continue the development of this molecule," said
NKTR-181 is a novel mu-opioid agonist molecule designed to have a slow rate of entry into the brain to reduce the attractiveness of the molecule as a target of abuse and to reduce other CNS-mediated side effects, such as sedation and respiratory depression.
Analyst Call to be Held
The company will be hosting a call to discuss these data with analysts and investors at
A live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investor Relations section of the Nektar website: http://www.nektar.com. To access the conference call live, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 71977583 (
The webcast replay of the conference call will be available through
About Opioids and Pain Management
Pain is one of the most common reasons people seek medical treatment.1
Nektar's technology has enabled eight approved products in the U.S. or
Nektar is headquartered in
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential for NKTR-181 as a potentially new analgesic opioid therapy for the treatment of chronic pain based on observations and findings from Phase 2 clinical data, potential future clinical develop plans for NKTR-181, and the value and potential of our technology and other drug candidates in our research and development pipeline. 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) NKTR-181 is in the clinical development stage and could fail at any time due to numerous unpredictable and significant risks related to safety, efficacy and other important findings that can negatively impact clinical development prior to approval of a drug candidate; (ii) future develop plans for NKTR-181 are preliminary only and subject to change based on, among other factors, our continued review of the clinical study results and interactions with health authorities; (iii) the preliminary topline results reported in this press release are subject to change based on final audit and verification procedures; (iv) although we have conducted various experiments using laboratory and home-based chemistry techniques that have so far been unable to convert NKTR-181 into a rapid-acting, more abusable opioid, it is possible that an alternative chemistry technique or process may be discovered in the future that would enable the conversion of NKTR-181 into a more abusable opioid; (v) the statements regarding the therapeutic potential of NKTR-181 as an opioid analgesic are based on our findings and observations from preclinical and clinical data and results from future clinical studies for NKTR-181 may fail to confirm these earlier findings and observations; (vi) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of Nektar's technology platform to potential new drug candidates such as NKTR-181 is very uncertain and unpredictable and these potential new drug candidates could unexpectedly fail at any time; (vii) patents may not issue from our patent applications for NKTR-181, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (viii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the
Nektar Investor and Media Inquiries:
(3) IMS, NSP,
(4) Melnikova, I, Pain Market, Nature Reviews Drug Discovery, Volume 9, 589-90 (August 2010).
(5) Morbidity and Mortality Weekly Report (MMWR), Emergency Department Visits Involving Nonmedical Use of Selected Prescription Drugs ---
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