Naldemedine

(Symproic®)

Naldemedine

Drug updated on 9/4/2024

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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  • Symproic (naldemedine) is 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 opioid dosage escalation.
  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Naldemedine significantly increased spontaneous bowel movement (SBM) responder rates in both cancer and non-cancer patients, showing improved bowel function over two weeks in cancer patients with opioid-induced bowel dysfunction (RR 1.93, 95% CI 1.36 to 2.74) and a higher SBM response rate compared to placebo (56.4% vs. 34.7%, p<0.00001).
  • Compared to other treatments, naldemedine produced more SBMs than magnesium oxide, naloxegol, and alvimopan, and demonstrated a significant benefit in preventing opioid-induced constipation (OIC) with a relative risk of 2.07 (95% CI 1.64-2.61) compared to placebo.
  • In cancer patients, naldemedine was effective in producing more SBMs compared to alvimopan and naloxegol, but there was a higher incidence of serious adverse effects in this subgroup compared to non-cancer patients.
  • The most common adverse event associated with naldemedine was diarrhea, observed across multiple studies, with a higher incidence compared to other treatments.
  • Serious adverse events were more frequently reported in the naldemedine group, particularly among cancer patients, with a higher overall incidence in this subgroup.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Symproic (Naldemedine) Prescribing Information.2020BioDelivery Sciences International, Inc., Raleigh, NC

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines