Efficacy and safety of nicoboxil/nonivamide ointment for the treatment of acute pain in the low back – A randomized, controlled trial

BACKGROUND: Until now, nonivamide/nicoboxil ointment has not been tested in a randomized trial for the treatment of acute non‐specific low back pain. METHODS: This phase III randomized, double‐blind, active‐ and placebo‐controlled, multi‐centre trial investigated efficacy, safety and tolerability of topical nicoboxil 2.5%/nonivamide 0.4% for treatment of acute non‐specific low back pain [primary endpoint: pain intensity (PI) difference between pre‐dose baseline and 8 h after the first application]. RESULTS: Patients (n = 805), 18–74 years of age were treated for up to 4 days with nicoboxil 2.5%/nonivamide 0.4%, nicoboxil 2.5%, nonivamide 0.4% or placebo ointment. Pre‐dose baseline pain intensity (6.6 on a 0‐ to 10‐point numerical rating scale) was reduced by 1.049 points with placebo, by 1.428 points with nicoboxil, by 2.252 points with nonivamide and by 2.410 points with nicoboxil/nonivamide after 8 h (p < 0.0001 for nicoboxil/nonivamide vs. placebo, nicoboxil; p = 0.4171 for nicoboxil/nonivamide vs. nonivamide). At the end of treatment, the combination provided more pronounced PI reduction (3.540 points) compared with nicoboxil (2.371, p < 0.0001), nonivamide (3.074, p = 0.0259) and placebo (1.884, p < 0.0001). Low back mobility scores on Day 1 were better for the combination compared with all other treatments (p < 0.044); on Day 2–4, scores were better than for placebo and nicoboxil (p < 0.003). Patients assessed efficacy of the combination as greater than of the comparators (p ≤ 0.0129). All treatments were tolerated well. No treatment‐related serious adverse events were reported. CONCLUSION: Nicoboxil/nonivamide ointment is an effective, well‐tolerated medication for the treatment of acute non‐specific low back pain.