NUCYNTA ER (tapentadol): WELL‑DEFINED TOLERABILITY PROFILE

INCIDENCE OF TEAEs REPORTED BY ≥2% OF SUBJECTS WITH cLBP1

Chart showing study on subjects with chronic low back pain who received at least one dose of study drug Chart showing study on subjects with chronic low back pain who received at least one dose of study drug

  • At cLBP study end, 95.2% [59/62] of patients receiving NUCYNTA ER experienced no opioid withdrawal after abrupt discontinuation of treatment without tapering2*
  • In vitro studies did not reveal any potential of NUCYNTA ER to either inhibit or induce cytochrome P450 enzymes3
    • A minor amount of NUCYNTA ER is metabolized via the oxidative pathway
    • Thus, clinically relevant interactions mediated by the cytochrome P450 system are unlikely to occur
CR: Controlled release; ER: extended release; TEAEs: treatment‑emergent adverse events.
  • The most common reasons for discontinuation due to adverse reactions in eight phase 2/3 pooled studies reported by ≥1% in any NUCYNTA ER dose group for NUCYNTA ER- and placebo‑treated patients were nausea (4% vs 1%), dizziness (3% vs <1%), vomiting (3% vs <1%), somnolence (2% vs <1%), constipation (1% vs <1%), headache (1% vs <1%), and fatigue (1% vs <1%), respectively3

*Oxycodone CR was included in the study as an active control. No opioid withdrawal after abrupt discontinuation was experienced by 91.1% (82/90) of patients in the oxycodone CR group2

References:
  1. Data on file, Collegium Pharmaceutical, Inc.
  2. Buynak R, Shapiro DY, Okamoto A, et al. Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double‑blind, placebo‑ and active‑controlled phase III study. Expert Opin Pharmacother. 2010;11(11):1787‑1804.
  3. NUCYNTA ER [package insert]. Stoughton, MA: Collegium Pharmaceutical, Inc.; December 2023.