Pain Relief Over Time
Results from a Pivotal Phase 3 trial assessing SUBSYS for the treatment of breakthrough pain
- The primary endpoint of Summed Pain Intensity Differences at 30 minutes post treatment (SPID30) was achieved with SUBSYS
- Pain Relief was achieved at all time points measured starting at 5 minutes (5, 10, 15, 30, 45, and 60 minutes)
A randomized, double-blind, placebo-controlled study designed to determine the efficacy of SUBSYS enrolled 130 adult opioid-tolerant patients with BTCP into open-label titration. 98 patients entered the double-blind period, and 96 patients were evaluable. The dose range studied was from 100 mcg per dose to 1600 mcg per dose. Patients rated Pain Relief (PR) using a 5-point categorical scale, with 1 being no relief, 2 being a little relief, 3 as moderate relief, 4 as a lot of relief and 5 being complete relief.
Pain Intensity Difference (PID) was calculated as the difference in pain intensity at each time interval relative to the baseline pain intensity. Summed Pain Intensity Difference (SPID) was calculated as the cumulative sum of PID scores across time. The primary endpoint was the Summed Pain Intensity Difference at 30 minutes post-dose (SPID30).
SELECTED IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- The use of SUBSYS in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
- Patients treated with SUBSYS who have significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of SUBSYS.
- Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.
- Administer SUBSYS with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) as SUBSYS may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure.