Movantik (naloxegol) / AstraZeneca, Nektar Therap, RedHill, Kyowa Kirin, Knight Therap, Grunenthal - LARVOL DELTA

PS04 Peripheral opioid pathway antagonists: a novel therapy for idiopathic chronic pruritus and nodular prurigo. (PubMed, Br J Dermatol) - "Naloxegol and naldemedine are peripherally acting μ-opioid receptor antagonists used in the treatment of opioid-induced constipation. Only one patient reported mild gastrointestinal side-effects immediately after commencing therapy; however, they continued with treatment and this subsided shortly after. These results suggest that peripheral μ-opioid receptor antagonists have the potential to be an effective treatment option for chronic pruritus; however, further studies are needed to confirm their efficacy."

Journal • CNS Disorders • Constipation • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Prurigo Nodularis • Pruritus

The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients (clinicaltrials.gov) - P3 | N=370 | Recruiting | Sponsor: University Hospital, Brest | Trial completion date: Apr 2026 ➔ Sep 2026 | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • CNS Disorders • Gastrointestinal Cancer • Vascular Neurology

Combined Efficacy of Methylnaltrexone and Naloxegol in Managing a Case of Neurogenic and Opioid-Induced Constipation (ACG 2025) - "His bowel regimen is polyethylene glycol 17g 3 times a day, lubiprostone 24mcg daily, 2 tablet of senna 8.6mg twice daily, and naloxegol 12.5mg daily. (2020), which show methylnaltrexone's efficacy in opioid-treated patients. While promising, further research is needed to assess the long-term safety and efficacy of this combined approach in similar patient populations."

Clinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Multiple Sclerosis

Letter: Optimizing Naloxegol Prescribing for Opioid-Induced Constipation. (PubMed, J Palliat Med) - No abstract available

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

MRI ASSESSMENT OF ACUTE COLONIC VOLUME RESPONSES TO OPIOIDS AND NALOXEGOL IN HEALTHY SUBJECTS: INTERIM RESULTS FROM A RANDOMISED, DOUBLE-BLIND CROSSOVER STUDY (UEGW 2025) - "During each visit, five abdominal MRI scans (each 20 min.) are obtained at 30 min intervals, at baseline, after drug intake, after a standardized 44 g oatmeal and 100 mL Nutridrink (313 kCal) meal, after a second drug dose, and after a bisacodyl 10 mg suppository administration. Interim MRI analysis of 8 HVs suggests different colonic motility responses across groups and timepoints. Toilet visits were suppressed in both codeine groups. Different responses to drug and food intake were found in the ascending and descending colon between the naloxegol+codein and double placebo group on one hand compared to the codein+placebo group."

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder

DOUBLE-BLIND PLACEBO-CONTROLLED CROSS-OVER MRI STUDY EVALUATING THE ACUTE EFFECT OF CODEINE AND NALOXEGOL ON GASTRIC CONTENT VOLUMES AND MOTILITY IN HEALTHY VOLUNTEERS (UEGW 2025) - "in between the scans, comprising one baseline fasted MRI, one MRI after the intake of either of the three drug combinations: 25 mg naloxegol + 60 mg codeine, 60 mg codeine + placebo, or double placebo, one after a standardized meal with 44 g oatmeal and 100 mL Nutridrink (313 kCal), followed by an MRI scan after a second dose of either 30 mg codeine or placebo, and a final scan after a bisacodyl 10 mg suppository administration. Interim analysis of 10 HVs using cine-MRI revealed significant codeine-induced delays in gastric emptying compared to placebo. However, no significant differences were currently observed between codeine with and without naloxegol, and this will be reassessed on the entire study sample size. Nevertheless, gastric motility revealed only a tendency toward more contractility of the whole stomach but not of the antrum with placebo."

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder

Postoperative administration of naloxegol after spinal deformity surgery: analysis of 234 patients. (PubMed, J Neurosurg Spine) - "Postoperative naloxegol had no significant impact on bowel function recovery or markers of POI after spinal deformity surgery. Patients with a history of opioid exposure required fewer consultations and imaging. Further research is required to understand whether pre-induction administration impacts POI and return to bowel function."

Journal • Constipation • Diabetes • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Movement Disorders

Perioperative Naloxegol use in prevention of post-operative ileus in open radical cystectomy (UAA 2025) - "Among these, Alvimopan is well-studied and has demonstrated reductions in postoperative ileus, length of hospital stay (LOS), and associated healthcare costs, particularly in procedures such as radical cystoprostatectomy. In this retrospective cohort, perioperative Naloxegol use did not confer a measurable benefit in accelerating gastrointestinal recovery following open radical cystectomy. Despite similar baseline characteristics, Naloxegol was associated with a significantly longer hospital stay and showed no reduction in time to flatus, bowel motion, resumption of diet or complication rate. These findings question the routine use of Naloxegol in this setting and underscore the need for prospective studies to better define its role in enhanced recovery protocols."

Treatment of Opioid-Induced Constipation: Inducing Laxation and Understanding the Risk of Gastrointestinal Perforation. (PubMed, J Clin Gastroenterol) - "Management of OIC includes treatment with over-the-counter laxatives and peripherally acting μ-opioid receptor antagonists (PAMORAs; methylnaltrexone, naloxegol, naldemedine). Appropriate patient selection during laxation therapy for OIC, regardless of treatment plan, involves consideration of the overall risk versus benefit in patients at increased risk of perforation due to comorbid medical conditions, concurrent medications, or recent gastrointestinal procedures. After initiating treatment for OIC, clinicians should assess the effectiveness of laxation therapy and carefully monitor for signs of gastrointestinal perforation."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Naloxegol for the Treatment of Opioid-Induced Constipation in Patients with Cancer Pain: A Pooled Analysis of Real-World Data. (PubMed, Cancers (Basel)) - "Our results support the use of naloxegol for the management of OIC in patients with cancer pain who do not respond to laxative treatment."

Journal • Real-world evidence • Retrospective data • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

Effects of naloxegol on transit recovery in patients undergoing cardiac surgery: A randomized, double-blind, placebo-controlled trial. (PubMed, Anaesth Crit Care Pain Med) - P3 | "Naloxegol was not found to be effective in improving the transit time recovery after elective cardiac surgery. The trial was registered on clinicaltrials.gov (NCT04433390) on June 16, 2020."

Clinical • Journal • Anesthesia • Cardiovascular • Diabetes • Gastrointestinal Disorder • Hypertension • Metabolic Disorders • Pain

Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database. (PubMed, Expert Opin Drug Saf) - "We conducted a pharmacovigilance analysis based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze the adverse events of six constipation drugs (linaclotide, lubiprostone, prucalopride, naloxegol, naldemedine, and plecanatide) and to search for clinically meaningful adverse reaction signals. The adverse reactions of constipation drugs were mainly gastrointestinal symptoms such as diarrhea, abdominal pain and abdominal distension. Linaclotide has the highest safety, and more studies are needed to analyze the cardiovascular safety of lubiprostone."

Adverse events • Journal • P4 data • Real-world evidence • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients (clinicaltrials.gov) - P3 | N=370 | Recruiting | Sponsor: University Hospital, Brest | Trial completion date: Sep 2026 ➔ Apr 2026 | Trial primary completion date: Mar 2026 ➔ Oct 2025

Trial completion date • Trial primary completion date • CNS Disorders • Gastrointestinal Disorder • Vascular Neurology

Comparing Rates of Postoperative Complications after Colorectal Surgery with Naloxegol versus Alvimopan (ASHP 2024) - No abstract available

Surgery

Effect of Alvimopan and Naloxegol for PostOperative Ileus in a Community Hospital (ASHP 2024) - No abstract available

Clinical

Evaluating OpioidInduced Constipation Management Naloxegol Use in the Inpatient Setting (ASHP 2024) - No abstract available

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder

Naldemedine Without Rescue Laxatives Versus Either Laxatives or Naloxegol in the Treatment of Opioid Induced Constipation Among Adults With Chronic Non-Cancer Pain (ISPOR-EU 2024) - "In patients with OIC and chronic non-cancer pain, naldemedine proved superior to not only rescue laxatives when used either as monotherapy or in combination with an established laxative regimen but also to naloxegol 25mg monotherapy in LIR patients."

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

New dynamic scoring method for deep evaluation of naloxegol as β-tubulin binding inhibitor. (PubMed, Pak J Pharm Sci) - "This method identified an ideal FDA-approved drug as β-tubulin microtubule inhibitor with improved attributes compared to commercial microtubule disassembly inhibitor, Paclitaxel (PTX). MD data underwent normalization, PCA analysis and scoring against PTX. One Naloxegol derivative scored higher than PTX as a potential microtubule disassembly inhibitor."

Journal • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology

Emerging therapies for opioid-induced constipation: what can we expect? (PubMed, Expert Opin Pharmacother) - "Key topics included the efficacy of peripherally acting mu-opioid receptor antagonists (PAMORAs) such as methylnaltrexone, naloxegol, and naldemedine, which specifically target opioid-induced gut dysfunction. Other treatment options, including intestinal secretagogues like lubiprostone and linaclotide, selective 5-HT receptor agonists such as prucalopride, and emerging adjunctive therapies like transcutaneous electrical nerve stimulation (TENS) and electroacupuncture were mentioned...Emerging therapies and adjunctive treatments offer promising results but require further validation through rigorous studies. Future research should focus on long-term outcomes, cost-effectiveness, and comparative effectiveness to better address the complex needs of patients with OIC and refine treatment protocols."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Population Pharmacokinetics of Naloxegol in Pediatric Subjects Receiving Opioids. (PubMed, Clin Pharmacol Drug Dev) - "Exposures in the other pediatric groups were similar to those in adult equivalent doses. The PK of naloxegol were characterized as linear over the dose range, with no clinically significant covariates and comparable PK characteristics in adults and pediatric subjects aged 6 months or older."

Journal • PK/PD data • Constipation • Gastroenterology • Gastrointestinal Disorder • Pediatrics

NALOXEGOL RESTORES CODEINE-INDUCED INHIBITION OF HIGH-AMPLITUDE PROPAGATING CONTRACTIONS AND INCREASE OF RETROGRADE CONTRACTIONS IN A RANDOMIZED, THREE-WAY CROSSOVER COLONIC HIGH-RESOLUTION MANOMETRY STUDY IN HEALTHY VOLUNTEERS (DDW 2024) - "Conclusion Codeine administration enhances retrograde contractions including HARPCs and inhibits antegrade HAPCs after intraluminal bisacodyl administration in healthy volunteers and these effects are reversed by naloxegol. These observations enhance our understanding of the mechanisms underlying OIC and its treatment with naloxegol."

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Opioid-induced Constipation: Old and New Concepts in Diagnosis and Treatment. (PubMed, J Neurogastroenterol Motil) - "Peripherally acting μ-opioid receptor antagonists, such as methylnaltrexone, naloxegol, or naldemedine, should be used in patients that have not responded to the first-line treatments. The bowel functional index is the main tool for assessing the severity of OIC and for monitoring the response. The paper discusses the recent literature on the pathophysiology, clinical evaluation, and management of OIC and provides a pragmatic approach for its assessment and treatment."

Journal • Review • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

A Systematic Review of Naldemedine and Naloxegol for the Treatment of Opioid-Induced Constipation in Cancer Patients. (PubMed, Pharmacy (Basel)) - "Naldemedine or naloxegol appeared safe and useful in the treatment of OIC in cancer patients and may improve their quality of life. Larger-scale randomized placebo-controlled studies of PAMORAs in cancer patients would strengthen existing evidence."

Clinical • Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients (clinicaltrials.gov) - P3 | N=370 | Recruiting | Sponsor: University Hospital, Brest | Trial completion date: Sep 2024 ➔ Sep 2026 | Trial primary completion date: Mar 2024 ➔ Mar 2026

Trial completion date • Trial primary completion date • CNS Disorders • Gastrointestinal Disorder • Vascular Neurology

Naloxegol Health Outcome Post Authorisation Safety Study (clinicaltrials.gov) - P=N/A | N=10000 | Terminated | Sponsor: Kyowa Kirin Pharmaceutical Development Ltd | Recruiting ➔ Terminated; Not feasible to reach the required number of patient cases by the defined end of data collection milestone (Q4 2022) knowing that the study completion was planned by the end of 2023

HEOR • Trial termination • Constipation • Gastroenterology • Gastrointestinal Disorder • JAK2