- Patients with chronic low back pain (CLBP) who received a new molecular entity mu-opioid receptor agonist, NKTR-181, experienced opioid withdrawal symptoms less often and with less severity than patients who received a placebo.
- Withdrawal symptoms were rare whether patients abruptly discontinued NKTR-181 or followed a 1-week drug taper.
Why this matters
- These findings, along with earlier results from this phase 3 clinical trial showing significantly greater pain relief with NKTR-181 compared with placebo, suggest the drug may be an effective treatment for CLBP with less risk for opioid withdrawal.
- Phase 3, enriched-enrollment, double-blind, randomized-withdrawal, 12-week study of 1190 patients with CLBP.
- Funding: Nektar Therapeutics.
- Patients who received NKTR-181 vs placebo had mild withdrawal at:
- Day 8: 1.0% vs 2.4%.
- Day 15: 1.4% vs 0.4%.
- 1 week after the end of study: 2.3% vs 0.5%.
- No significant withdrawal symptoms were observed in patients receiving NKTR-181 vs placebo (P=.0545).
- No comparison of NKTR-181 with conventional mu-opioid agonists.
- Short duration of study.
Coauthored with Vijay Rathod, PhD.