Anjeso (meloxicam IV) / Baudax Bio - LARVOL DELTA

Meloxicam and levamisole administration ameliorates FMD vaccination stress on frozen semen attributes in Sahiwal bulls. (PubMed, Sci Rep) - "The present study was conducted at the Artificial Breeding Research Centre, ICAR-NDRI, Karnal, Haryana, with twelve Sahiwal breeding bulls that were divided into four groups: Group I (Control), Group II (Meloxicam), Group III (Levamisole), and Group IV (Meloxicam + Levamisole). The meloxicam + levamisole group exhibited significantly lower (p < 0.05) sperm abnormalities and lipid peroxidation. Improvement was observed in semen quality with treatment (Meloxicam + levamisole-treated bulls) in percentage of live (+ 53.11%), moribund (- 33.83%), dead (- 36.70%), apoptotic spermatozoa (- 44.01%), and DNA fragmentation index (- 47.07%) in relation to the control groups on the 7th post vaccination day."

Journal • Allergy

Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-severe Pain Following Abdominal Surgery (clinicaltrials.gov) - P3 | N=224 | Completed | Sponsor: Yangtze River Pharmaceutical Group Co., Ltd.

New P3 trial • Pain

Safety, Tolerability and Pharmacokinetics of Meloxicam Nanocrystal Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Yangtze River Pharmaceutical Group Co., Ltd.

New P1 trial • Pain

Pharmacokinetic profile of a single intramuscular or oral dose of meloxicam in red kangaroos (Osphranter rufus). (PubMed, Am J Vet Res) - "Four additional kangaroos received a 0.2-mg/kg dose of meloxicam, IV, to establish bioavailability. IM meloxicam may offer advantages to PO dosing due to the greater Cmax and longer t1/2. Nonsteroidal anti-inflammatory drugs are known to decrease platelet function, and it is unknown if red kangaroos are at increased risk for hemorrhage following the administration of meloxicam compared to other species."

Journal • PK/PD data • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders

Intravenous Meloxicam versus Intravenous Ketorolac for Pain Control Following Total Joint Arthroplasty: a Randomized Controlled Trial (AAOS 2025) - P3 | "Pain scores, nausea scores, and opioids required (morphine milligram equivalents [MME]), were assessed at 2 and 24 hours postoperatively. The intraoperative administration of IV meloxicam for TJA resulted in a significant increase the amount of opioids (MME) required by 24 hours postoperatively and longer lengths of stay when compared to IV ketorolac. Though the once daily dosing schedule of IV meloxicam may be more convenient, IV ketorolac is superior for the perioperative management of patients undergoing."

Clinical • Gastrointestinal Disorder • Orthopedics • Pain

Assessing Facial Thermal Nociceptive Response in Female Dogs After Elective Ovariohysterectomy Anesthetized with Isoflurane and Treated with Cannabidiol and Meloxicam Analgesia. (PubMed, Animals (Basel)) - "G1: Placebo group (n = 16); G2: Group receiving intravenous meloxicam as premedication (0.2 mg Kg-1) and every 24 h postoperatively 0.1 mg Kg-1 (n = 16); G3: Group treated with CBD (n = 16) at a dose of 2 mg kg-1 orally every 12 h; and G4: Group medicated with the combination of both treatments (n = 16). No significant correlation was found between the temperatures of the assessed thermal regions and the physiological traits. In conclusion, CBD, whether administered alone or in combination with meloxicam, demonstrated comparable analgesic efficacy, which could control nociceptive cardiorespiratory and hemodynamic autonomic responses, as there were no significant changes in the facial thermal response between treatments G2, G3 and G4."

Journal • Anesthesia • Gynecology • Pain

Bupivacaine multivesicular liposomes/meloxicam nanocrystals in a thermosensitive gel adapted to the "microenvironment" for long-term analgesia. (PubMed, Eur J Pharm Biopharm) - "Sciatic nerve block models and hot plate analgesia tests demonstrated that H-MVL/MLX@GEL effectively alleviated pain for at least five days. The immunohistochemical results showed that the addition of MLX reduced the production of the local inflammatory factors interleukin-6 (IL-6) and tumour necrosis factor-α (TNF-α), thereby improving the analgesic effect by regulating the local acidic environment and alleviating local irritation."

Journal • Oncology • Pain • IL6 • TNFA

Effects of early treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) on the bronchoalveolar lavage proteome and oxylipids during bovine respiratory syncytial virus (BRSV) infection. (PubMed, PLoS One) - "Four to nine-week old calves were infected with BRSV by aerosol and were treated with either meloxicam intravenously on day (D)4 (n = 5, MEL), acetylsalicylat-DL-lysin intravenously on D4 and D5 (n = 5, ASA), or were left untreated as controls (n = 5, CTR)...The risk of NSAIDs to increase neutrophil activity during stimulation with BRSV or other toll-like receptor 4 agonists needs to be investigated further. Since augmented neutrophil responses can be detrimental, the results of the present study do not support the use of NSAIDs to prevent the clinical expression of BRSV-infection."

IO biomarker • Journal • Infectious Disease • Inflammation • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections • TLR4

Bioequivalence of Meloxicam Nanocrystal Injection in Healthy Chinese Volunteers. (PubMed, Clin Pharmacol Drug Dev) - "Additionally, four subjects (16.7%) experienced five instances of adverse events in the T group, while five subjects (21.7%) experienced five instances of adverse events in the R group. This trial indicated the potential bioequivalence between the T and R products under fasting conditions, based on pharmacokinetic and safety profile."

Journal • Pain

The Comparative Efficacy of IV and Oral Analgesics for Third Molar Dental Extraction Pain (IASP 2024) - "IV diclofenac, meloxicam ketorolac, and oral acetaminophen/ ibuprofen combination had values > 0.63 while celecoxib, indomethacin, and tramadol were substantially lower. Our results demonstrate a high degree of efficacy for IV meloxicam, diclofenac, and ketorolac with a maximum responder rates (i.e., those reaching ?50% – MaxGRO) of 76%, 85% and 83% respectively but onset times of 43min and a duration of >17 hours for meloxicam. Diclofenac and ketorolac had onsets of 30 minutes and 6-hour durations. Onset for acetaminophen and ibuprofen was 60 minutes with durations of 6-8 hours, vs onset of 15 minutes for IV acetaminophen, but the duration as only 3 hours."

Clinical • Pain

PHAROS, a real-world multi-country European study on patients with high-risk localised and locally advanced prostate cancer receiving radical treatment. (ASCO 2024) - "EFS at 5 years was 48 % [0.43-0.54] in the RP cohort (N=1539), and 74% [0.66-0.81] in the RT cohort (N=764)... In this large RWD cohort of HR LPC & LAPC, initial results suggest that a significant proportion of patients fail after primary curative treatment within 5 years, indicating an unmet medical need to improve outcomes. Further analysis of the PHAROS dataset will bring better understanding of the real-world patient pathway in this setting and the role of intermediate endpoints."

Clinical • Metastases • Real-world • Real-world evidence • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Assessing estimated glomerular filtration rate (GFR) equation performance compared to measured-GFR stratified for ethnicity and albumin: AIM CKD UK study development – analysis of 2623 patients (UKKW 2024) - "The majority of patients were White ethnicity (58.7%; N=1539)...Future data analysis for the AIM CKD study can include paired samples within 30 days as there is no significant difference between 0-7 and 8-30 days. The impact of serum albumin on mGFR-eGFR association in a larger cohort stratified for confounding variables, such as liver disease, malignancy and body mass index is required."

Clinical • Cardiovascular • Chronic Kidney Disease • Hepatology • Oncology • Renal Disease

Assessing eGFR performance against measured GFR stratifying for ethnicity and albumin: Development of the AIM CKD UK study (ERA-EDTA 2024) - "The majority of patients were White ethnicity (58.7%; N=1539)... The LM revised and European Kidney Function Consortium equations perform best in this cohort. Limitations include selection bias and retrospective data. Future data analysis for the AIM CKD study can include paired samples within 30 days as there is no significant difference between 0-7 and 8-30 days."

Cardiovascular • Chronic Kidney Disease • Hepatology • Oncology

GENDER DIFFERENCES IN VASCULAR ACCESS FOR PREVALENT DIALYSIS PATIENTS (ERA-EDTA 2024) - "The characteristics of prevalent HD pts in 2021 (n=4270) were different for male (n=2731) vs female (n=1539) regarding mean age (69.1±14.6 vs 70.9±14.3 years), age bracket >74 years (42.4% vs 48.3%), median time on HD [24.0 (9.8−48.2) vs 27.6 (10.5−59.1)], aetiology of ESKD as polycystic kidney disease (4.4% vs 7.2%), normal functional status (38.0% vs 28.4%), cardiovascular disease (76.3% vs 71.1%) and obesity rate (body mass index BMI>30 kg/m2: 17.4% vs 27.2%) (for all comparisons, p<0.001)... 1) AVF was the main type of VA used for prevalent men on HD, but AVF and tunnelled catheter shared this ranking in women. 2) Male gender was an independent factor associated with a 58% greater probability of performing HD through AVF than female. 3) The percentage of prevalent HD pts dialyzed through AVF progressively decreased over time in both sexes but it was always higher in men than women."

Clinical • Cardiovascular • Genetic Disorders • Nephrology • Obesity • Polycystic Kidney Disease

Refinement of the motorised laminectomy-assisted rat spinal cord injury model by analgesic treatment. (PubMed, PLoS One) - "I) tramadol (5mg/kg) and buprenorphine (0.05mg/kg); II) carprofen (5mg/kg) and buprenorphine (0.05mg/kg); III) carprofen (5mg/kg); IV) meloxicam (1mg/kg) and buprenorphine (0.05mg/kg); V) meloxicam (1mg/kg); and VI) no analgesia (0.5 ml sterile saline). Weekly Basso Beattie and Bresnahan (BBB) scores served as markers for functionality together with Novel Object Recognition test (NOR) at week 8 and terminal histopathology using area of vacuolisation and live neuronal count from the ventral horns of spinal cord. It was concluded that the usage of analgesia improved animal wellbeing while having no effects on the functional aspects of the animal model in comparison to the animals that received no analgesics."

Journal • Preclinical • CNS Disorders • Orthopedics • Pain

Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery (clinicaltrials.gov) - P4 | N=19 | Terminated | Sponsor: Baudax Bio | N=90 ➔ 19 | Recruiting ➔ Terminated; Anjeso (N1539) NDA Withdrawn

Enrollment change • Surgery • Trial termination • Pain

Disposition kinetics of meloxicam in green sea turtles (Chelonia mydas) after intravenous and intramuscular administrations. (PubMed, J Vet Pharmacol Ther) - "These results suggested that i.m. administration of MLX at a dosage of 0.2 mg/kg b.w. was likely to be effective for clinical use in green sea turtles (Chelonia mydas). However, further studies are needed to determine the pharmacodynamic properties and clinical efficacy of MLX for the treatment of inflammatory disease after single and multiple dosages."

Journal • Inflammation

Age-related changes in the pharmacokinetics of meloxicam after intravenous administration in sheep. (PubMed, J Vet Pharmacol Ther) - "Compared to 1-month-old and 12-month-old sheep, there was no difference in these parameters in 6-month-old sheep. Because the age of sheep has an influence on the pharmacokinetics of meloxicam, dosage apparently may need to be adjusted for age."

Journal • PK/PD data

PHARMACOKINETICS OF ORAL FLUNIXIN MEGLUMINE, MELOXICAM, OR GABAPENTIN IN THREE BLACK RHINOCEROS (DICEROS BICORNIS). (PubMed, J Zoo Wildl Med) - "Pharmacokinetics of single, separate doses of IV flunixin meglumine (1 mg/kg), IV meloxicam (0.5 mg/kg), oral flunixin meglumine (1 mg/kg), oral meloxicam (1 mg/kg), and oral gabapentin (15 mg/kg) in three adult black rhinoceroses (Diceros bicornis) were determined from serial blood collection made over 72 h. The concentration versus time profiles were analyzed for each drug and route in each individual rhinoceros, and individual pharmacokinetic parameters were calculated for each medication administered. Oral flunixin meglumine achieved a lower C (range 170.67-664.38 ng/ml) in this study compared with the mean C (1,207 ng/ml) reported in a similar study in white rhinoceroses (Ceratotherium simum), but some overlap in range of values was noted. Oral flunixin meglumine T (range 1.05-10.78 h) and half-life (range 3.88-14.85 h) values in black rhinoceroses was similar to mean values reported in white rhinoceroses (3 and 8.3 h, respectively)."

Journal • PK/PD data

Meloxicam for Pain Management After Total Joint Arthroplasty (TJA) (clinicaltrials.gov) - P3 | N=231 | Completed | Sponsor: University of Miami | Recruiting ➔ Completed

Trial completion • Musculoskeletal Diseases • Orthopedics • Pain

"@FiercePharma Any thoughts on Alkermes receiving the rights to Anjeso back from Baudax Bio?" (@jrm2734)

Analgesic efficacy of an ultrasound-guided transversus abdominis plane block with bupivacaine in cats: a randomised, prospective, masked, placebo-controlled clinical trial. (PubMed, J Feline Med Surg) - "A bilateral ultrasound-guided two-point TAPB with bupivacaine in combination with systemic buprenorphine provided superior postoperative analgesia than buprenorphine alone in cats undergoing ovariohysterectomy."

Clinical • Journal • Anesthesia • Gynecology • Pain

Intramuscular alfaxalone with or without buprenorphine or hydromorphone provides sedation with minimal adverse effects in healthy rabbits (Oryctolagus cuniculus) in a randomized blinded controlled trial. (PubMed, J Am Vet Med Assoc) - "All 3 treatments provided reliable sedation; however, alfaxalone (4 mg/kg, IM) combined with hydromorphone (0.1 mg/kg, IM) may be a better choice for painful procedures."

Adverse events • Clinical • Journal • Preclinical • Anesthesia • Pain

Meloxicam for Pain Management After Total Joint Arthroplasty (TJA) (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: University of Miami | Trial completion date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Orthopedics • Pain

Preclinical studies of a high drug-loaded meloxicam nanocrystals injection for analgesia. (PubMed, Colloids Surf B Biointerfaces) - "The acetic acid-induced writhing tests, hot plate tests and hind paw incision experiments demonstrated that the MLXNCs had significant analgesic effects. The findings provide insights into the developed high drug-loaded MLXNCs and provide new therapeutic options for acute and chronic pain management."

Journal • Preclinical • Pain