title: Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain - a randomized, placebo-controlled trial.
abstract: OBJECTIVE
  Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC) of nonivamide (a capsaicinoid) and nicoboxil (a nicotinic acid ester) cream in the treatment of acute nonspecific low back pain.
  
  
  METHODS
  This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1.08%/nonivamide 0.17% (Finalgon®cream) in treatment of acute nonspecific low back pain with the endpoints: pain intensity (PI) difference between pre-dose baseline and 8 hours after first application and the end of treatment, mobility score, and efficacy score.
  
  
  RESULTS
  Patients (n=138), 21-65 years of age, were treated for up to 4 days with FDC or placebo cream. Mean baseline PI was 6.8 on a 0-10 point numerical rating scale. After 8 hours, pain was more reduced with the FDC than with placebo (adjusted means: 2.824 vs. 0.975 points;p<0.0001). On the last treatment day, mean pain reduction by the FDC was stronger than with placebo (adjusted means: 5.132 vs. 2.174 points;p<0.0001). Mobility on Day 1 was in favor of the FDC when compared to placebo (odds ratio [95% confidence interval {CI}]: 7.200 [3.609, 14.363],p<0.0001). At the end of treatment, patients treated with the FDC rated efficacy significantly higher than placebo (odds ratio [95% CI]: 11.370 [5.342, 24.199],p<0.0001). Both treatments were tolerated well. No serious adverse events were reported.
  
  
  CONCLUSIONS
  Nicoboxil/nonivamide cream is an effective and safe treatment for acute nonspecific low back pain, adding a promising treatment option.
authors.affiliation: Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria.
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Blahova
authors.affiliation: Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria.
authors.forename: Janina Claudia
authors.initials: JC
authors.lastname: Holm
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Weiser
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany.
authors.forename: Erika
authors.initials: E
authors.lastname: Richter
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Trampisch
authors.affiliation: I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
authors.forename: Elena
authors.initials: E
authors.lastname: Akarachkova
keywords: Finalgon®; efficacy; mobility score; pain reduction