Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced topline results from the first completed IMPROVE study in its prospective Phase 4 clinical program. The study was designed to compare the difference in three primary endpoints—cost, opioid consumption and hospital length of stay (LOS)—between one group of patients receiving a standard opioid-based postsurgical pain management regimen and a second group of patients receiving EXPAREL ® (bupivacaine liposome injectable suspension) as the foundation of an opioid-sparing multimodal regimen.
The EXPAREL-based multimodal regimen achieved a statistically significant reduction in each primary endpoint, including a 60 percent reduction in LOS in patients undergoing open colectomy, a surgical procedure to remove all or part of the colon through an incision in the abdominal wall. EXPAREL is a non-opioid local analgesic indicated for administration into the surgical site to produce postsurgical analgesia. The overall safety profile for EXPAREL was consistent with previous experiences in the Phase 3 program.
“Results of this study, coupled with the results of our pivotal soft tissue trial, where EXPAREL demonstrated a 30 percent reduction in pain and a 45 percent reduction in opioid use through 72 hours following excisional hemorrhoidectomy, help to quantify the impact a non-opioid foundation such as EXPAREL can have on our postsurgical patients,” said Dave Stack, president and CEO of Pacira. “We look forward to seeing the data from the remainder of the IMPROVE study sites and sharing these results in the public domain.”
Southern Regional Medical Center is the first site to complete a prospective, open-label IMPROVE study. These studies will be carried out in up to five institutions across the United States. Colorectal surgeon Stephen M. Cohen, MD, FACS, FASCRS at Southern Regional Medical Center was the primary investigator of this study and performed all surgeries included in the study population. Eighteen patients were enrolled in the opioid-based group; 21 patients were enrolled in the EXPAREL-based multimodal regimen group.