MALVERN, PA — Baudax Bio, Inc. (NASDAQ: BXRX), a pharmaceutical company focused on therapeutics for acute care settings, announced a virtual poster presentation highlighting new Phase IIIb ANJESO® (meloxicam) injection clinical data at the American Society of Colon and Rectal Surgeons (ASCRS) 2020 Annual Scientific Meeting.
“The data published virtually this year by the ASCRS supports the use of ANJESO® administered preoperatively as part of an Enhanced Recovery After Surgery (ERAS) protocol to patients prior to undergoing colorectal surgery,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio.
“The key findings from this study include statistically significant reductions in opioid use, as well as faster time to bowel function recovery and earlier hospital discharge. These positive results will inform our future physician education initiatives as we support the ongoing commercial launch of ANJESO.”
The virtual presentation describes clinical outcomes from a randomized, placebo-controlled Phase IIIb study evaluating 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 explored in this study including opioid consumption, return of bowel function, and hospital length of stay.
The incidence of individual adverse events (AEs) were comparable between groups or numerically lower in the meloxicam IV group. The majority of AEs were mild or moderate in severity. The incidence of serious AEs was also higher in the placebo group.
ANJESO-treated patients experienced statistically significant reductions in opioid consumption (35%; p<0.05), in time to first bowel sounds (59%; p<0.05), time to first bowel movement (18%; p<0.05), and time to hospital discharge (27%; p<0.05), all compared to placebo.
This study supports 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.
Title: Safety and Efficacy of Preoperative Meloxicam IV in Colorectal Surgery
Lead Author: Conor Delaney
Presentation #: MED.0320-136.a
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