NKTR-192 is a new mu-opioid agonist molecule designed to have a short-acting profile and onset of pain relief suitable for the treatment of acute pain, but with a reduced rate of entry into the CNS as compared to other fast-acting opioids used to treat acute pain, such as Vicodin® and Percocet®.
"With prescription opioid abuse at epidemic levels in
The second Phase 1a clinical study will assess the pharmacodynamic profile and tolerability of single ascending doses of NKTR-192 in up to 48 healthy subjects. The Phase 1 clinical development program is being conducted in
"Results from our first clinical study of NKTR-192 demonstrated that this new mu-opioid molecule achieved a short-acting pharmacokinetic profile which is ideal for the treatment of acute pain," continued Dr. Medve. "In our second clinical study, we will measure multiple pharmacodynamic endpoints, including indicators of CNS entry and models of analgesia in healthy volunteers. NKTR-192 is an excellent addition to Nektar's pain portfolio and we look forward to the continued development of this new mu-opioid analgesic molecule in the clinic."
In preclinical studies, NKTR-192 has demonstrated a reduced rate of entry into the central nervous system, demonstrating the potential to greatly reduce the euphoria that underlies opioid abuse and dependence, as well as other unwanted CNS side effects, such as sedation. The unique characteristics of NKTR-192 are physically engineered into its new molecular design so its potential differentiating properties are inherent to the molecule.
About NKTR-192
NKTR-192 is
About Opioids and Pain Management
Approximately 140 million prescriptions are written annually in the U.S. for acute and sub-chronic pain indications, such as muscle injuries, post-operative pain, and kidney stones.1,2 Although prescription opioids are considered the most effective treatment for moderate-to-severe pain, their abuse has been identified by the
Rapid-acting opioids enter the brain quickly, frequently causing a euphoric effect, or drug-related "high" which results in high potential for substance abuse, addiction and diversion. In addition to the potential to be abused, opioids can also cause drowsiness, impacting a patient's ability to function normally. The pharmaceutical industry has invested heavily in the development of new formulations of these drugs in order to combat the abuse and diversion of these painkillers. However, these reformulations have been primarily focused on physical means of deterrence, and abusers have found ways to overcome these formulation barriers.
About Nektar
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" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of NKTR-192 including the potential for NKTR-192 to exhibit reduced abuse potential and side effects typically associated with comparable mu-opioid medicines and the value and potential of certain other drug candidates in our R&D 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 potential of our drug candidates, 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, the following: (i) our statements regarding the potential therapeutic potential of NKTR-192 are based on preclinical and early Phase 1 data only and
future clinical study results may not confirm one or more of these potential therapeutic benefits; (ii) NKTR-192 is in the very early stages of clinical development 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 drug development; (iii) while we have conducted numerous experiments using laboratory and home-based chemistry techniques that have not been able to convert NKTR-192 into a rapid-acting and more abusable opioid, there is a risk that in the future a technique could be discovered to convert NKTR-192 into a rapid-acting and more abusable opioid which would significantly diminish the value of this drug candidate; (iv) the
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1 Harstall,
2 IMS, NSP,
3 Melnikova, I, Pain Market, Nature Reviews Drug Discovery, Volume 9, 589-90 (
SOURCE
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