학술논문
Long-term Safety and Tolerability of NKTR-181 in Patients with Moderate to Severe Chronic Low Back Pain or Chronic Noncancer Pain: A Phase 3 Multicenter, Open-Label, 52-Week Study (SUMMIT-08 LTS).
Document Type
Academic Journal
Author
Gudin J; Department of Anesthesiology, Rutgers New Jersey Medical School, Newark, New Jersey.; Pain Management and Wellness Center, Englewood, New Jersey.; Rauck R; Carolinas Pain Institute and The Center for Clinical Research, Winston-Salem, North Carolina.; Argoff C; Department of Neurology, Albany Medical Center, Albany, New York.; Agaiby E; Clinical Investigation Specialists Inc, Kenosha, Wisconsin.; Gimbel J; Arizona Research Center, Phoenix, Arizona.; Katz N; Tufts University School of Medicine, Boston, Massachusetts.; Analgesic Solutions, Wayland, Massachusetts.; Doberstein SK; Nektar Therapeutics, San Francisco, California.; Tagliaferri M; Nektar Therapeutics, San Francisco, California.; Tagliaferri M; Nektar Therapeutics, San Francisco, California.; Potts J; Great Lakes Research Group, Inc, Bay City, Michigan.; Wild J; Upstate Clinical Research Associates, Williamsville, New York.; Lu L; Nektar Therapeutics, San Francisco, California.; Siddhanti S; Nektar Therapeutics, San Francisco, California.; Hale M; Gold Coast Research, LLC, Plantation, Florida.; Markman J; Department of Neurosurgery, Translational Pain Research Program, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.
Source
Publisher: published by Oxford University Press on behalf of the American Academy of Pain Medicine Country of Publication: England NLM ID: 100894201 Publication Model: Print Cited Medium: Internet ISSN: 1526-4637 (Electronic) Linking ISSN: 15262375 NLM ISO Abbreviation: Pain Med Subsets: MEDLINE
Subject
Language
English
Abstract
Objective: To evaluate the long-term safety of NKTR-181, a novel mu-opioid receptor agonist that may have reduced human abuse potential, in patients with moderate to severe chronic low back pain (CLBP) or other chronic noncancer pain (CNP).
Design: Uncontrolled, multicenter, open-label, long-term study of NKTR-181 comprised of three periods: screening (≤21 days), treatment (52 weeks), and safety follow-up (∼14 days after the last dose of NKTR-181).
Setting: Multicenter, long-term clinical research study.
Methods: NKTR-181 administered at doses of 100-600 mg twice daily (BID) was evaluated in opioid-naïve and opioid-experienced patients. Patients were enrolled de novo or following completion of the randomized, placebo-controlled phase 3 efficacy study (SUMMIT-07). Safety assessments included adverse event documentation, measurements of opioid withdrawal, and clinical laboratory tests. Effectiveness was assessed using the modified Brief Pain Inventory Short Form (mBPI-SF).
Results: The study enrolled 638 patients. The most frequently reported treatment-emergent adverse events (TEAEs) were constipation (26%) and nausea (12%). Serious TEAEs, reported in 5% of patients, were deemed by investigators to be unrelated to NKTR-181. There were no deaths or reported cases of respiratory depression. A sustained reduction in mBPI-SF pain intensity and pain interference from baseline to study termination was observed throughout treatment. Only 2% of patients discontinued NKTR-181 due to lack of efficacy, and 11% discontinued due to treatment-related AEs. NKTR-181 doses of up to 600 mg BID were generally well tolerated, and patients experienced low rates of opioid-related adverse events.
Conclusions: The study results support the premise that NKTR-181 is a safe and effective option for patients with moderate to severe CLBP or CNP.
(© 2019 American Academy of Pain Medicine.)
Design: Uncontrolled, multicenter, open-label, long-term study of NKTR-181 comprised of three periods: screening (≤21 days), treatment (52 weeks), and safety follow-up (∼14 days after the last dose of NKTR-181).
Setting: Multicenter, long-term clinical research study.
Methods: NKTR-181 administered at doses of 100-600 mg twice daily (BID) was evaluated in opioid-naïve and opioid-experienced patients. Patients were enrolled de novo or following completion of the randomized, placebo-controlled phase 3 efficacy study (SUMMIT-07). Safety assessments included adverse event documentation, measurements of opioid withdrawal, and clinical laboratory tests. Effectiveness was assessed using the modified Brief Pain Inventory Short Form (mBPI-SF).
Results: The study enrolled 638 patients. The most frequently reported treatment-emergent adverse events (TEAEs) were constipation (26%) and nausea (12%). Serious TEAEs, reported in 5% of patients, were deemed by investigators to be unrelated to NKTR-181. There were no deaths or reported cases of respiratory depression. A sustained reduction in mBPI-SF pain intensity and pain interference from baseline to study termination was observed throughout treatment. Only 2% of patients discontinued NKTR-181 due to lack of efficacy, and 11% discontinued due to treatment-related AEs. NKTR-181 doses of up to 600 mg BID were generally well tolerated, and patients experienced low rates of opioid-related adverse events.
Conclusions: The study results support the premise that NKTR-181 is a safe and effective option for patients with moderate to severe CLBP or CNP.
(© 2019 American Academy of Pain Medicine.)