Baudax Bio Announces Presentation of New Phase IIIb ANJESO Data at the American Society of Colon and Rectal Surgeons 2020 Annual Scientific Meeting
Virtual Presentation Highlights New ANJESO Clinical Results, Including Safety, Reductions in Opioid Use and Time to Bowel Function Recovery Data When Administered Preoperatively Prior to Colorectal Surgery
MALVERN, Pa., July 30, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today 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.