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 (CONTINUED): Addiction, Abuse, and Misuse (continued)

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing NUCYNTA tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

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. Collegium Pharmaceutical, Inc. (EDJD).