NUCYNTA®: WELL-DEFINED TOLERABILITY1

Oxycodone IR was included in the study as an active control to confirm the sensitivity of the pain models1

DISCONTINUATION RATES DUE TO TEAEs IN AN END-STAGE DEGENERATIVE JOINT DISEASE STUDY1
Chart showing discontinuation rates due to TEAEs in an end-stage degenerative joint disease study Study Design +
  • Safety population (N=666): All subjects with end-stage degenerative joint disease receiving at least 1 study drug intake following randomization

TEAEs=treatment-emergent adverse events.

ADVERSE REACTIONS:

The most common reasons for discontinuation due to adverse reactions in the studies described above (reported by ≥1% in any NUCYNTA® dose group) were dizziness (2.6% vs 0.5%), nausea (2.3% vs 0.6%), vomiting (1.4% vs 0.2%), somnolence (1.3% vs 0.2%) and headache (0.9% vs 0.2%) for NUCYNTA®- and placebo-treated patients, respectively. Seventy-six percent of NUCYNTA®-treated patients from the 9 studies experienced adverse events.

Study design:

In a multicenter, randomized, double-blind, active- and placebo-controlled, parallel group, phase 3 study, subjects who were candidates for joint replacement surgery due to end-stage joint disease (N=659) were selected to assess the efficacy and safety of NUCYNTA®. Patients were randomized 1:1:1:1 to receive NUCYNTA® 50 mg, 75 mg, oxycodone IR 10 mg, or placebo. Patients received study drug every 4 to 6 hours during waking hours for 10 days. The primary efficacy endpoint was the sum of pain intensity difference (SPID) over 5 days.1

NUCYNTA®: WELL-DEFINED TOLERABILITY (CONTINUED)1,2

Oxycodone IR was included in the study as an active control to confirm the sensitivity of the pain models1,2

INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS (TEAEs) REPORTED IN ≥2% OF PATIENTS IN ANY TREATMENT GROUP IN AN END‑STAGE DEGENERATIVE JOINT DISEASE STUDY2

Chart showing NUCYNTA® incidence of treatment

Study Design +
  • Safety population (N=666): All subjects with end-stage degenerative joint disease receiving at least 1 study drug intake following randomization
  • Incidence of TEAEs: Based on the number of subjects experiencing at least 1 adverse event, not the number of events
WARNINGS AND PRECAUTIONS: Accidental Exposure:

Instruct patients against use by individuals other than the patient for whom NUCYNTA® was prescribed and to keep NUCYNTA® out of the reach of children, as such inappropriate use may result in fatal respiratory depression.

Study design:

In a multicenter, randomized, double-blind, active- and placebo-controlled, parallel group, phase 3 study, subjects who were candidates for joint replacement surgery due to end-stage joint disease (N=659) were selected to assess the efficacy and safety of NUCYNTA®. Patients were randomized 1:1:1:1 to receive NUCYNTA® 50 mg, 75 mg, oxycodone IR 10 mg, or placebo. Patients received study drug every 4 to 6 hours during waking hours for 10 days. The primary efficacy endpoint was the sum of pain intensity difference (SPID) over 5 days.1

References
  1. Hartrick C, Van Hove I, Stegmann J-U, Oh C, Upmalis D. Efficacy and tolerability of tapentadol immediate release and oxycodone HCI immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active- and placebo controlled study. Clin Ther. 2009;31(2):260-271.
  2. Data on file. Depomed, Inc: 2007 (EDJD).