NUCYNTA ER (tapentadol): THE FIRST AND ONLY OPIOID PROVEN TO TREAT CHRONIC LOW BACK PAIN (cLBP) AND THE NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY (DPN)1,2

IMPROVEMENT IN MEAN cLBP INTENSITY AT WEEK 12 OF MAINTENANCE PERIOD3*

Chart showing improvement in mean pain intensity at week 15 from baseline as measured by NRS

  • STUDY DESIGN3
  • Prospective, randomized, double‑blind, active‑ and placebo-controlled, multicenter, phase 3 study in patients with moderate to severe chronic low back pain in the US, Canada, and Australia (n=958, ITT)
  • Patients were randomized in a 1:1:1 ratio to receive NUCYNTA ER, oxycodone CR, or placebo
  • Oxycodone CR (n=326, ITT) with average daily dose of 67‑75 mg was included as active control to confirm assay sensitivity
  • PRIMARY EFFICACY ANALYSIS3
  • Based on the LOCF imputation method
  • Treatment comparisons used the ANCOVA model and were based on LS mean difference from placebo as measured by NRS
  • PRIMARY ENDPOINT3
  • Change from baseline in mean pain intensity at week 12 of the maintenance period (week 15 of the study), as measured by NRS*

ANCOVA: analysis of covariance; ITT: intent‑to‑treat; LOCF: last observation carried forward; LS: least squares; NRS: numerical rating scale.



NUCYNTA ER: ONE SOURCE OF RELIEF

Watch a clinical presentation on NUCYNTA ER for appropriate patients with chronic low back pain.

IMPROVEMENT IN MEAN NEUROPATHIC PAIN INTENSITY4

Chart showing efficacy of NUCYNTA<sup>®</sup> ER was maintained over 12 weeks vs placebo
  • STUDY DESIGN4
  • Double‑blind, parallel‑group, randomized‑withdrawal, placebo‑controlled, multicenter, phase 3 study in patients with painful diabetic peripheral neuropathy
  • The trial had two main phases: in the 3‑week open‑label phase, NUCYNTA ER responders (n=389, ITT) received either placebo (n=193, ITT) or NUCYNTA ER (n=196, ITT) 100‑250 mg BID for a 12‑week double‑blind maintenance phase
  • PRIMARY EFFICACY ANALYSIS4
  • Based on the LOCF imputation method
  • Treatment comparisons used the ANCOVA model and were based on LS mean difference from placebo
  • PRIMARY ENDPOINT4
  • Change from baseline in average pain intensity over the last week (week 12) of the double‑blind maintenance period as measured by the NRS (week 15 of the study; US)

ANCOVA: analysis of covariance; ITT: intent‑to‑treat; LOCF: last observation carried forward; LS: least squares; NRS: numerical rating scale.

References:
  1. NUCYNTA ER [package insert]. Stoughton, MA: Collegium Pharmaceutical, Inc.; 2019.
  2. OxyContin [package insert]. Stamford, CT: Purdue Pharma LP; 2019.
  3. 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 Ill study. Expert Opin Pharmacother. 2010;11(11):1787‑1804.
  4. Schwartz S, Etropolski M, Shapiro DY, et al. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized‑withdrawal, placebo‑controlled trial. Curr Med Res Opin. 2011;27(1):151-162.
  5. Data on file, Collegium Pharmaceutical, Inc.