Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 0.2 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 five systematic review(s)/meta-analysis(es). [1-5]
- Naldemedine vs. Placebo: Naldemedine showed significantly higher response rates in treating opioid-induced constipation (OIC) in cancer patients, doubling the risk of spontaneous laxations (relative risk (RR) 2.00, 95% confidence interval (CI) 1.59 to 2.52) over two weeks. It was ranked first in network meta-analysis for achieving three or more bowel movements per week (odds ratio (OR) 2.8, 95% credible interval (CrI) 2-4.5).
- Naldemedine vs. Other Peripherally Acting Mu-Opioid Receptor Antagonists (PAMORAs): Naldemedine had higher response rates compared to methylnaltrexone (RR 2.07, 95% CI 1.64-2.61) and produced more spontaneous bowel movements compared to alvimopan.
- Subgroup Analysis: Naldemedine demonstrated significant effectiveness in cancer patients, with consistent findings across multiple studies focused on this subgroup.
- Common Adverse Events: Naldemedine treatment was associated with increased rates of diarrhea and abdominal pain, with non-serious adverse events being more frequent compared to placebo.
- Serious Adverse Events: There was no significant difference in serious adverse events between naldemedine and placebo (RR 3.34, 95% CI 0.85 to 13.15).
- Naldemedine demonstrated significant effectiveness in cancer patients, improving bowel function and quality of life, with studies focusing on cancer and palliative care patients showing broad applicability across different stages of cancer.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Symproic (naldemedine) Prescribing Information. | 2020 | BioDelivery Sciences International, Inc., Raleigh, NC |
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) |
Pharmacological prevention and treatment of opioid-induced constipation in cancer patients: A systematic review and meta-analysis | 2024 | Cancer Treatment Reviews |
Mu-opioid antagonists for opioid-induced bowel dysfunction in people with cancer and people receiving palliative care | 2022 | The Cochrane Database of Systematic Reviews |
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 |
Efficacy and Safety of Peripherally Acting Mu-Opioid Receptor Antagonists for the Treatment of Opioid-Induced Constipation: A Bayesian Network Meta-analysis | 2020 | Pain Medicine (Malden, Mass.) |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Naldemedine for treating opioid-induced constipation. | 2020 | National Institute for Health and Care Excellence |
American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation. | 2019 | Gastroenterology |