MALVERN, PA — Baudax Bio, Inc. (NASDAQ: BXRX), a pharmaceutical company focused on therapeutics for acute care settings, announced that the results of the Phase IIIb study evaluating ANJESO (meloxicam) injection administered preoperatively prior to colorectal surgery were published online in the journal Pain Management. ANJESO is the Company’s marketed, non-opioid, once daily, intravenous (IV) non-steroidal anti-inflammatory (NSAID) agent for use in adults for the management of moderate to severe pain that is indicated for use alone or in combination with other non-NSAID analgesics.
“Adequate pain relief is an important component of ERAS (enhanced recovery after surgery) protocols and is associated with various beneficial effects, including shorter length of stay (LOS), enhanced recovery, faster mobilization and better patient satisfaction,” said Jennifer Silinsky, MD, Colorectal Surgeon, Tulane University School of Medicine, and lead author of the manuscript. “Opioids have historically been a mainstay of perioperative pain control, however, an important goal of ERAS protocols is to reduce opioid consumption, which in turn may lead to decreased known opioid-related risks and adverse events. In this study, both groups received a standardized ERAS protocol that included pain control and the results demonstrated that ANJESO was superior to placebo when added to the ERAS regimen. In addition, ANJESO was generally well tolerated, with over 92% of patients reporting satisfaction with their post-operative pain medication. ANJESO-treated patients also experienced statistically significant reductions in opioid consumption, time to first bowel sounds, time to first bowel movement and time to hospital discharge, all compared to placebo. These data support the efficacy and safety of ANJESO administered once daily, with administration beginning prior to start of surgery, as part of a standardized multimodal regimen in patients undergoing colorectal procedures.”
“We are honored to have these data published by such a well-regarded medical journal to be shared with the anesthesia, pain management and surgical community,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. “We believe the successful outcome of this study represents an important advancement for colorectal surgery physicians and their patients and we are sincerely grateful to all of the patients and investigators who participated in the study. The ANJESO launch is progressing well and these positive results will continue to inform our ongoing physician education initiatives as we work to drive adoption of ANJESO.”
The full manuscript can be accessed here.
Summary of the Phase IIIb Results
This multi-center, randomized, double-blind, placebo-controlled Phase IIIb study evaluated preoperative doses of ANJESO in 55 patients undergoing bowel resection and/or anastomosis. Patients were randomized 1:1 to receive ANJESO or placebo with the first dose administered 30 minutes prior to the start of surgery, then every 24 hours on top of a standardized ERAS protocol that included a multimodal pain management plan in addition to study treatment; all patients received gabapentin 300mg once prior to surgery, and acetaminophen 650mg starting prior to surgery and continuing every 8 hours until 24 hours after the last dose of study medication. Following surgery, opioid rescue was available upon request. The primary objective of the study was to assess the safety of ANJESO when administered pre-operatively, with a key measure being the incidence and severity of adverse events. Numerous additional efficacy parameters were also assessed in this study, including various pain outcomes (e.g., patient global assessment [PGA], brief pain inventory [BPI], etc.), opioid consumption, return of bowel function, healthcare resource utilization and hospital length of stay.
For safety, the incidence of individual adverse events (AEs) was comparable between groups and was numerically lower in the ANJESO group. ANJESO was generally well tolerated. The most common treatment-emergent AEs (TEAEs) in both study groups were nausea and vomiting and the majority of these were mild or moderate in intensity. The incidence of serious AEs was also comparable between groups and numerically lower in the ANJESO group. None of the SAEs was considered related to study medication and all resolved. For AEs commonly associated with opioid use (e.g., nausea, vomiting and ileus) the incidence rate was either comparable to the placebo group or lower in the ANJESO group.
Opioid consumption was lower in the ANJESO-treated group at all time intervals, and the differences versus placebo were statistically significant at some time points. Total opioid consumption was 35% lower in the ANJESO group (p=0.03). The largest difference in opioid consumption occurred on post-surgery Day 2 (hour 24-48), when ANJESO was associated with 49% lower opioid consumption (p=0.01). Overall, patients treated with ANJESO received 16.9mg fewer opioids, compared to placebo-treated patients, (49.25mg vs 66.14mg, p=0.04).
While patients in the placebo group had higher opioid use, ANJESO-treated patients had similar or better pain scores and similar patient satisfaction. BPI was significantly lower for the ANJESO group on postoperative Day 1 (p=0.03). For other BPI time intervals, there were no meaningful differences between the study groups. Most subjects in both the ANJESO (92.3%) and placebo (92.6%) groups were satisfied with their postoperative pain medication. There were no significant differences in PGA of pain control between the groups.
Healthcare Resource Utilization
The mean time from end of surgery to actual hospital discharge and mean total LOS were significantly shorter (28 hours) for the ANJESO group. There was no significant difference in total cost of hospital stay between the study groups, although costs in the ANJESO group, but not the placebo group, were driven by outliers. Regression analysis demonstrated that increased opioid consumption was associated with increased LOS, with every 1mg increase in opioid consumption from hour zero to discharge was associated with a 0.58-hour increase in LOS (p=0.0005). Surgery type (bowel resection vs other) was significantly associated with total costs and LOS, with the highest costs linked to bowel resection.
The mean times to first bowel sound, first flatus and first bowel movement were significantly shorter in the ANJESO group (p=0.02, p=0.03 and p=0.02, respectively). Mean times to first ambulation were similar between the ANJESO and placebo groups.
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