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

CR: Controlled release; ER: extended release; TEAEs: treatment‑emergent adverse events.
  • 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 enzymes
    • 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 occur3
  • 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%), respectively

*Oxycodone CR was included in the study as an active control to confirm the sensitivity of the pain models. 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.; 2018.