NKTR-181 for Chronic Lower Back Pain: SUMMIT-07 Results
Compared with standard opioids, NKTR-181 has a slower rate of entry into the central nervous system.
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DENVER – For patients with moderate to severe chronic low back pain, NKTR-181 100 to 400 mg twice daily significantly reduces pain with a low rate of adverse events, according to results presented at the American Association of Nurse Practitioners 2018 conference.
NKTR-181 is a new, full mu-opioid receptor agonist that has a slower rate of entry into the central nervous system compared with standard opioids.
SUMMIT-07 (ClinicalTrials.gov Identifier: NCT02362672) included participants with moderate to severe back pain who were opioid naive (n=610). Participants were randomly assigned to receive NKTR-181 (n=309) or placebo (n=301). The primary end point was change in weekly pain score from baseline to week 12, and secondary end points were percentages of study completers with week 12 pain scores reduced ≥30% and ≥50%, as well as adverse events.
At week 12, the NKTR-181 group had a least-squares mean change in weekly pain scores from baseline of +0.92 compared with +1.46 for those receiving placebo (P =.0019), indicating a significantly greater analgesic effect with treatment.
In the NKTR-181 group, 71.2% of participants had pain reductions of ≥30% at week 12, and 51.5% had ≥50% reductions compared with 57.1% and 37.9%, respectively, for those receiving placebo (P ≤.001).
Adverse events were reported by 54.4% of participants in the NKTR-181 group and 49.8% in the placebo group. Few instances of central nervous system-related adverse events commonly associated with opioids were reported in the treatment group (<3%).
Disclosure: The study was sponsored by Nektar Therapeutics.
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Markman J, Gudin J, Rauck R, et al. Efficacy, safety, and tolerability of NKTR-181 in patients with moderate to severe chronic low-back pain: a phase 3 study. Presented at the American Association of Nurse Practitioners 2018 National Conference. June 26-July 1, 2018; Denver, CO. Poster 11.