MALVERN, PA — Baudax Bio, Inc. (NASDAQ: BXRX), a pharmaceutical company focused on therapeutics for acute care settings, announced a virtual poster presentation highlighting ANJESO™ (meloxicam) injection data at Digestive Disease Week (DDW) 2020.
“The data virtually published by DDW demonstrate that ANJESO has positive impacts on many elements of healthcare resource utilization when administered preoperatively to patients prior to colorectal surgeries as part of a multimodal analgesic (MMA) regimen,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. “Key findings included statistically significant reductions in opioid use and in length of hospital stay by approximately 1 day, as well as lower incidence of opioid-related adverse events, all while achieving similar or slightly reduced average cost of the hospital stay. We are thrilled ANJESO is now available for ordering and delivery to U.S. customers, and we are actively preparing for the full commercial launch by June 2020.”
The virtual presentation describes an economic sub-study of a double-blind, placebo-controlled Phase IIIb study evaluating preoperative administration of ANJESO as part of a MMA regimen compared to placebo in 55 patients who had undergone open or laparoscopic colorectal surgeries. The Phase IIIb study was designed to replicate conditions consistent with current clinical practice, including use of a standardized enhanced recovery after surgery protocol based on common best practices for colorectal surgeries. Patients were randomized 1:1 to receive ANJESO (30mg) or placebo. The first study dose was administered 30 minutes prior to the start of surgery. Subsequent doses of ANJESO were administered every 24 hours. The primary objective of the Phase IIIb study was to evaluate the safety and tolerability of preoperative dosing of ANJESO in subjects undergoing open or laparoscopic colorectal surgeries compared to placebo. The economic sub-study primary objective was to evaluate the impact of preoperative dosing of ANJESO on healthcare resource use (HRU) and healthcare costs.
HRU Results Following Preoperative ANJESO Compared to Placebo
This economic sub-study evaluated HRU and costs, including total hospital costs, hospital length of stay (LOS) and opioid use associated with preoperative administration of ANJESO compared to placebo. A subject-level database was developed to capture quantity of service, charges and date of service from UB-04 forms (from admission date to discharge), captured in the IIIB clinical trial. A national cost:charge ratio was applied to convert ‘charges’ to ‘costs’.
A total of 55 subjects (mean age: 60, female: 43%) were treated in the trial, with 54 subjects included in HRU analysis (n=27 per treatment; 1 excluded due to missing UB-04). The total mean costs of hospital stay were similar between the ANJESO group compared to the placebo group ($23,115 vs. $22,682; p=0.3370). After removing outliers (top 99th percentile), the total costs for the ANJESO group was numerically lower than the placebo group ($20,492 vs. $22,682; p=0.2196). Mean hospital LOS in days was numerically lower in the ANJESO group compared to the placebo group (86.2 vs. 111.7 hr; p=0.0162) and was statistically significant.
Mean total opioid use was significantly lower among the ANJESO group compared to placebo and from hour 0 through hospital discharge (29.22mg vs. 45.17mg; p<0.0339). The proportion of subjects with ≥1 opioid related adverse drug effects (ORADE) were higher for the placebo group than for the ANJESO group (63% vs. 41%). Presence of >1 ORADE was associated with a significant increase in LOS (exp (β)=1.303, p=0.0238) in hours (exp(β)=1.264, p =0.031) as compared to not having any ORADEs.
Title: Healthcare Resource Utilization (HRU) Associated with Preoperative Meloxicam IV in Colorectal Surgery
Lead Author: Libby Black
Presentation #: 503-2020
For more information on this meeting, visit www.ddw.org.
Thanks for visiting! MyChesCo brings reliable information and resources to Chester County, Pennsylvania. Please consider supporting us in our efforts. Your generous donation will help us continue this work and keep it free of charge. Show your support today by clicking here and becoming a patron.