Baudax Bio Announces Publication of Phase IIIb Data on Preoperative Administration of ANJESO®

Baudax Bio, Inc.

MALVERN, PA — Baudax Bio, Inc. (Nasdaq: BXRX), a pharmaceutical company focused on therapeutics for acute care settings, this week announced the online publication of data highlighting the safety and efficacy of preoperative ANJESO® (meloxicam) injection in patients undergoing unilateral total knee arthroplasty (TKA) when used within a multimodal analgesic regimen, in the peer-reviewed medical journal Pain Medicine. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.

Preemptive administration allows providers to better control pain at the outset of surgery, rather than waiting until inflammation and pain have already set in. Preoperative use of NSAIDs is recommended by the American Society for Enhanced Recovery (ASER) and the Perioperative Quality Initiative (POQI). Further multimodal analgesia involves the administration of 2 or more drugs that act by different mechanism for providing analgesia, the aim of which is to improve pain relief while reducing opioid requirements and opioid-related adverse effects.

“Patients typically report high levels of pain after orthopedic surgery and managing this pain can be challenging. In this study we administered ANJESO prior to the start of the surgery helping us to stay ahead of the pain. Which is a critical component of patient care,” said Richard Berkowitz, M.D., University Orthopedic and Joint Replacement Center, Tamarac, Florida. “In the past there has been a tendency to resort to opioids for pain control, given the risks associated with opioids such as addiction, gastrointestinal adverse events, pruritus, and respiratory depression, among others, there has been an increased need for alternative medications for patients undergoing elective or nonelective surgical procedures and it is encouraging to see these results.”

“The data published by Pain Medicine continues to support ANJESO as an advantageous option for the management of moderate to severe pain. The data not only highlight the efficacy and tolerability of ANJESO when administered preoperatively within a multimodal analgesic regimen to patients undergoing TKA, but also conveys a decreased need for opioids following surgery,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Baudax Bio. “The findings are especially compelling because they suggest select measures of health care resource utilization (HRU) also tended to be lower in the ANJESO treated group, including 10% lower mean total hospital charges. These data suggest ANJESO has a promising role in multimodal analgesic regimens in this clinical setting.”

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Efficacy and Safety Results Following Administration of Preoperative ANJESO Compared to Placebo

During the 1st 24 hours, ANJESO patients used ~32% less opioids and reported ~22% greater pain reduction relative to placebo treated patients. ANJESO-treated patients had a significantly lower Summed Pain Intensity score on the first postsurgical day and throughout their inpatient course (p≤0.0001). Additionally, ANJESO-treated patients had significantly lower opioid consumption during the first postsurgical day, with a 31.7% reduction compared to placebo (mean 19mg vs. 28mg; p<0.0001). Significant reductions in opioid use were observed on subsequent days and throughout treatment. ANJESO-treated patients had a significantly longer time to first opioid rescue after surgery compared to placebo treated patients. ANJESO-treated subjects had lower incidences of all cause hospital readmissions, fewer patients admitted to skilled nursing facilities upon discharge, and fewer emergency room visits, and doctor calls related to pain during the follow-up period.

With respect to safety, adverse events (AEs) were primarily mild or moderate in intensity and not related to study treatment, with a higher incidence of AEs reported in the placebo group. Additionally, the incidence of serious AEs was higher in the placebo group. All serious AEs in the ANJESO group were assessed by the primary investigators to be not related to study treatment. No subject discontinued due to an AE. The overall rate of AEs of special interest (AESI; events related to concerns associated with NSAIDS) were lower in the ANJESO-treated group at 9.7% than the placebo group at 21.6%. Rates of individual events in the ANJESO group occurred at similar or lower rates compared to the placebo group. Laboratory and surgical wound healing assessments were similar between treatment groups. 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 subjects undergoing primary unilateral TKA.

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Healthcare Resource Utilization (HRU) Results Following Preoperative ANJESO Compared to Placebo

This study also evaluated HRU and costs, including total hospital costs, hospital length of stay (LOS), hospital readmissions, ER visits, physician office visits, and phone calls due to pain, associated with preoperative administration of ANJESO compared to placebo, through postoperative day 30. This study was not powered to show statistical differences in HRU endpoints.

The total mean charges for the hospital stay, and total overall charges were lower in the ANJESO group compared to the placebo group, ($56,424 vs $62,864), however, the differences were not statistically significant. Mean hospital LOS in days was lower in the ANJESO group compared to the placebo group (2.05 vs. 2.24 days), which was 8.6% lower compared to placebo, however, the difference was not statistically significant. There were fewer hospital readmissions (1 vs. 3), ER visits (0 vs. 4), and phone calls due to pain (4 vs. 9) for ANJESO versus placebo, respectively. There were no reports of unscheduled physician office visits due to pain in either group.

Mean total opioid use from hour 0-24, 0-48, and 0-72 hours was significantly lower among meloxicam IV compared to placebo (p<0.0001) and from hour 0 through hospital discharge (33.28mg vs. 44.87mg); (p<0.001). Time to the first oral opioid rescue medication was longer for the ANJESO group than placebo (7.31 vs. 5.22 hours; p=0.0226) and a similar trend was observed for mean time to first use of IV or oral opioid analgesia (4.75 vs. 3.09 hours; p=0.0126). While there was no significant association between opioid consumption and total hospital charges, every unit (1mg IV morphine equivalent) increase in opioid consumption was associated with a 0.5% increase in LOS in days (p=0.0001). The proportion of subjects with ≥1 opioid related adverse drug effects were significantly higher for placebo than ANJESO (70.5% vs. 48.4%; p=0.003). Six ANJESO-treated patients (6.5%) had ≥1 AESI in comparison to 12 placebo subjects (13.6%). Serious AEs were observed among 3 ANJESO-treated patients (3.2%) and 9 placebo subjects (10.2%).

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The Overall Benefit of Analgesia Scores (OBAS) were also assessed. The OBAS is a simple, multi-dimensional quality assessment instrument to measure patients’ benefit from postoperative pain therapy. Opioid symptom distress, pain relief, and patients’ satisfaction are combined in a reliable and valid tool. A lower score indicates better pain management and lower opioid symptom distress. The OBAS score was significantly lower for meloxicam IV compared with placebo-treated subjects on the first postoperative day (LS mean [SE] 4.45 [0.360] vs 5.90 [0.375] for meloxicam and placebo, respectively; difference [95% CI], –1.45 [–2.39, –0.51]; P = 0.0027).

ANJESO® Phase IIIb Study Design

The study was designed to evaluate the effect of perioperative meloxicam IV on opioid consumption in primary TKA. This was a multicenter, randomized, double-blind, placebo-controlled trial and evaluated 181 adults undergoing elective primary TKA. Subjects received meloxicam 30 mg or placebo via IV bolus every 24 hours, with the first dose administered prior to surgery as part of a multimodal pain management protocol. The primary efficacy parameter was total opioid use over a 24-hour period following surgery. Findings from the study suggest perioperative meloxicam IV 30 mg as part of a multimodal analgesic regimen for elective primary TKA reduced opioid consumption in the 24-hour period following surgery versus placebo and was associated with a lower incidence of AEs typically associated with opioid use.

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