"With millions of patients suffering from chronic pain, there is a clear unmet medical need for better and safer pain medications," said Dr.
NKTR-181 is a new chemical entity (NCE) that was created using
"The investigators are pleased to see the start of this important first study in the SUMMIT Phase 3 program to evaluate the efficacy and safety of NKTR-181 in patients with chronic low back pain," said Dr.
NKTR-181 has been granted has been granted Fast Track designation for the treatment of moderate to severe chronic pain by the
SUMMIT-07 Study Design
The SUMMIT-07 Phase 3 trial utilizes an enriched-enrollment, randomized withdrawal (EERW) design and will enroll opioid-naïve patients ages 18 to 75 years who have had moderate to severe non-neuropathic chronic low back pain for at least six months. The study includes an open-label, dose titration period followed by a randomized, double-blind, placebo-controlled 12 week treatment period. During the open-label titration phase, study participants will be titrated on NKTR-181 tablets administered orally twice daily until they experience an adequate and sustained pain response. Patients who achieve this will then be randomized on a 1:1 basis to either continue to receive their analgesic dose of NKTR-181 or to receive placebo during the double-blind 12 week treatment period. A total of 208 patients will be randomized to each arm. No background NSAIDs are allowed throughout the study.
The primary endpoint of the study is a change in pain as measured by the change in a patient's weekly pain score from baseline to week 12 of the randomized, double-blind treatment period.
The SUMMIT Phase 3 program will also include a Phase 3 efficacy and safety trial in patients who are opioid-experienced (SUMMIT-12) as well as a 52-week long-term safety study (SUMMIT-LTS).
For more information on the SUMMIT-07 study, please visit https://www.clinicaltrials.gov/ct2/show/NCT02362672?term=nktr-181&rank=2
About Opioids and Pain Management
Pain is one of the most common reasons people seek medical treatment.i A study published in the
Opioids are considered the most effective therapeutic option for pain with 270 million prescriptions written in the U.S. alone in 2013.iiiiv The global opioid market for chronic pain, which includes chronic back pain, osteoarthritis, fibromyalgia and neuropathic pain, is estimated to be
MOVANTIK™ is a trademark of the AstraZeneca group of companies.
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the commercial launch of drugs may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iii) acceptance, review and approval decisions for new drug applications by health authorities is an uncertain and evolving process and health authorities retain significant discretion at all stages of the regulatory review and approval decision process; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of our technology platform to potential new drug candidates is therefore highly uncertain and unpredictable and one or more
research and development programs could fail; (v) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) the outcome of any existing or future intellectual property or other litigation related to our drug candidates and those of our collaboration partners. Other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the
iii IMS, NSP,
iv Melnikova, I, Pain Market, Nature Reviews Drug Discovery, Volume 9, 589-90 (August 2010).
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