NUCYNTA® ER (tapentadol): THE FIRST AND ONLY OPIOID PROVEN TO TREAT CHRONIC LOW BACK PAIN (cLBP) AND NEUROPATHIC PAIN ASSOCIATED WITH DPN

IMPROVEMENT IN MEAN cLBP INTENSITY* (N=981)1

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

  • STUDY DESIGN1
  • Double-blind, parallel-group, randomized, 15-week phase 3 study. Mean baseline pain intensity: 7.5 on 11-pt NRS*
  • Oxycodone controlled-release included as an active control
  • RESULTS1
  • Primary endpoint: Change in mean pain intensity from baseline to week 12 of the maintenance period (week 15 of the study) as measured by the NRS
  • NUCYNTA ER significantly reduced mean pain intensity compared with placebo (P<0.001)

*NRS: Numerical Rating Scale, an 11-point pain intensity scale, with a score of 0 being "no pain" and a score of 10 being "pain as bad as you can imagine."

Study design:
In a prospective, randomized, double-blind, active- and placebo-controlled, multicenter phase 3 study, subjects with moderate to severe chronic low back pain (N=981) were selected to evaluate the efficacy and safety of NUCYNTA ER. Subjects were randomized in a 1:1:1 ratio to receive controlled, adjustable doses of NUCYNTA ER (100-250 mg BID), oxycodone CR (20-50 mg BID), or placebo BID. This study was designed with a dose ratio of 5:1 for NUCYNTA ER to oxycodone CR. Therefore, 100 mg to 250 mg of NUCYNTA ER and 20 mg to 50 mg oxycodone CR were studied. The study was not designed to establish equianalgesic doses. Oxycodone CR was included for analgesic assay sensitivity and not as a head-to-head comparator. The study consisted of a screening period, a washout period, a 15-week treatment period (3-week double-blind titration period followed by a 12-week double-blind maintenance period), and a follow-up period. No breakthrough medication was allowed for low back pain during maintenance period. The primary efficacy endpoint was change from baseline in mean pain intensity at week 12 on the Numerical Rating Scale. The co-primary efficacy endpoint was change from baseline in mean pain intensity over the entire 12-week maintenance period. Of the 981 subjects in the study, 965 received at least one dose of study medication and were evaluated.1

NUCYNTA ER: Improvements in Patient-Reported Outcomes

Oxycodone CR was included in the study as an active control to confirm the sensitivity of the pain models.1

SECONDARY EFFICACY ENDPOINT, SF-36, IN A CHRONIC LOW BACK PAIN STUDY1
Chart showing NUCYNTA<sup>®</sup> ER versus Placebo and Oxycodone CR versus Placebo
Study Design +
  • Secondary efficacy endpoints: Short Form-36 (SF-36) survey evaluating 8 dimensions of health completed at baseline and at Weeks 1, 5, 9, and 12

IMPROVEMENT IN MEAN NEUROPATHIC PAIN INTENSITY* (n=395)2

Chart showing efficacy of NUCYNTA<sup>®</sup> ER was maintained over 12 weeks vs placebo
  • STUDY DESIGN3
  • Double‑blind, parallel-group, randomized‑withdrawal, 15‑week phase 3 study
  • In the 3‑week open‑label phase, 395 NUCYNTA ER responders were randomized either to placebo (n=196) or NUCYNTA ER (n=199) 100‑250 mg BID for a 12‑week double‑blind maintenance phase
  • RESULTS3
  • Primary endpoint: Change from baseline in average pain intensity over the last week (week 12) of the double-blind maintenance period as measured by the NRS*
  • NUCYNTA ER significantly reduced mean pain intensity compared with placebo (P<0.001)

Study design:
In a double-blind, parallel-group, enriched-enrollment randomized phase 3 study, subjects with chronic DPN were selected to assess the efficacy and safety of NUCYNTA ER. The study had a 3-week open-label phase (N=588) during which all subjects were titrated to their individual dose of NUCYNTA ER 100-250 mg BID. That was followed by a 12-week double-blind maintenance phase (N=389) during which subjects were randomized 1:1 to continue taking NUCYNTA ER or receive placebo. Supplemental analgesia was permitted. The primary efficacy endpoint was the change from baseline in mean pain intensity over week 12 of the maintenance period.2

NUCYNTA ER: Improvements in patient‑reported outcomes2

More than 64% of DPN patients reported overall pain status was “very much improved” or “much improved”

PATIENTS REPORTING OVERALL STATUS “VERY MUCH IMPROVED” OR “MUCH IMPROVED” AT THE END OF A 15‑WEEK DPN STUDY2
Chart showing more than 64% of DPN patients reported overall pain status was 'very much improved' or 'much improved' Adapted from Schwartz et al.

Study Design +

  • Secondary efficacy endpoint: Patient's global impression of change (PGIC) at Weeks 2, 6, and 12 of the double-blind phase as measured by a 7-point verbal rating scale*

*Patients rated their response to the statement, "Since I began my medication, my overall status is..." with a numerical range from 1 ("very much improved") to 7 ("very much worse").

References:
  1. 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.
  2. 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.
  3. Data on file. Collegium Pharmaceutical, Inc.