NUCYNTA®: ONE SOURCE OF RELIEF IN THE ACUTE SETTING1

NUCYNTA®: Powerful efficacy in post-surgical pain vs placebo

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

CHANGE IN MEAN PAIN INTENSITY OVER 48 HOURS IN A BUNIONECTOMY STUDY1

Chart showing sum of pain intensity difference (SPID) over the first 48 hours of treatment as measured by the 11-point Numerical Rating Scale (NRS) * P<0.001 based on all comparisons vs placebo.

Study Design +
  • Primary efficacy endpoint: Sum of pain intensity difference (SPID) over the first 48 hours of treatment as measured by the 11-point Numerical Rating Scale (NRS)
  • Primary efficacy analysis: Based on the intent-to-treat population who received at least 1 dose of study drug and had a valid baseline pain assessment
  • Mean baseline pain intensity score: 7.02

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."

WARNINGS AND PRECAUTIONS: Addiction, Abuse, and Misuse

NUCYNTA tablets contain tapentadol, a Schedule II controlled substance. As an opioid, NUCYNTA tablets expose users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA tablets. Addiction can occur at recommended dosages and if the drug is misused or abused.

Study design:

In a randomized, double-blind, active- and placebo-controlled, parallel, multicenter, phase 3 study, subjects with moderate to severe pain following bunionectomy (N=603) were selected to evaluate the efficacy and safety of NUCYNTA®. Subjects were randomized to receive NUCYNTA® 50 mg, 75 mg, or 100 mg, oxycodone IR 15 mg, or placebo. Subjects received study drug every 4 to 6 hours over 3 days on an inpatient basis. The primary efficacy endpoint was the SPID over the first 48 hours.1

NUCYNTA®: Powerful efficacy for moderate to severe acute pain vs placebo

Oxycodone IR was included in the study as an active control to confirm the sensitivity of the pain models3,4

CHANGE IN MEAN PAIN INTENSITY OVER 5 DAYS IN AN END-STAGE DEGENERATIVE JOINT DISEASE STUDY3,4
Chart showing change in mean pain intensity over 5 days in an end-stage degenerative joint disease study

* P<0.001 based on all comparisons vs placebo.

Study Design +
  • Primary efficacy endpoint: Sum of pain intensity difference (SPID) over the first 5 days of treatment as measured by the 11-point Numerical Rating Scale (NRS)
  • Primary efficacy analysis: Based on the intent-to-treat population who received at least 1 dose of study drug and had a valid baseline pain assessment using the last observation carried forward (LOCF) method
  • Mean baseline pain intensity score: 6.74

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."

WARNINGS AND PRECAUTIONS (CONTINUED): Addiction, Abuse, and Misuse (continued)

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing NUCYNTA tablets and monitor all patients receiving NUCYNTA tablets for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as NUCYNTA tablets, but use in such patients necessitates intensive counseling about the risks and proper use of NUCYNTA tablets along with intensive monitoring for signs of addiction, abuse, and misuse.

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 SPID over 5 days.3

References
  1. Daniels SE, Upmalis D, Okamoto A, Lange C, Häeussler J. A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain. Curr Med Res Opin. 2009;25(3):765-776.
  2. Data on file. Collegium Pharmaceutical, Inc. (Bun I).
  3. 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.
  4. Data on file. Collegium Pharmaceutical, Inc. (EDJD).