Drug updated on 11/1/2024
Dosage Form | Tablet (oral; 12.5 mg, 25 mg) |
Drug Class | Opioid antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Latest News
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- PAMORAs (Peripherally acting mu-opioid receptor antagonists), including methylnaltrexone, naloxegol, naldemedine, and alvimopan, were superior to placebo in alleviating opioid-induced constipation (OIC), with naloxegol improving bowel function indices and stool consistency, and naldemedine generating a higher frequency of spontaneous bowel movements (SBMs) than alvimopan and naloxegol.
- In cancer patients, both naldemedine and naloxegol demonstrated effectiveness and safety for OIC, potentially enhancing quality of life in this subgroup.
- Comparatively, naldemedine outperformed naloxegol in increasing SBMs, while oral methylnaltrexone showed a more rapid onset in reducing OIC symptoms than naloxegol.
- Common adverse effects of PAMORAs, including naloxegol and naldemedine, primarily involved gastrointestinal symptoms such as diarrhea and flatulence, with diarrhea noted as the most frequent side effect across these treatments.
- Serious adverse events were rare; however, some cardiovascular treatment-emergent adverse effects (TEAs) were observed with methylnaltrexone, though a definitive link to the drug was unclear, possibly reflecting underlying patient conditions.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Movantik (naloxegol) Prescribing Information. | 2023 | AstraZeneca |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
A Systematic Review of Naldemedine and Naloxegol for the Treatment of Opioid-Induced Constipation in Cancer Patients | 2024 | Pharmacy (Basel, Switzerland) |
Efficacy and Safety of Peripherally Acting mu-Opioid Receptor Antagonist (PAMORAs) for the Management of Patients With Opioid-Induced Constipation: A Systematic Review | 2021 | Cureus |
Systematic review with meta-analysis: efficacy and safety of treatments for opioid-induced constipation | 2020 | Alimentary Pharmacology & Therapeutics |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation. | 2019 | Gastroenterology |