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Naldemedine

(Symproic®)

Naldemedine

Drug updated on 12/11/2024

Dosage FormTablet (oral; 0.2 mg)
Drug ClassOpioid 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.

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Summary
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  • 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.