Naldemedine

(Symproic®)

Symproic®

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Drug updated on 5/17/2024

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.

Summary
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  • Naldemedine (Symproic) is indicated for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain, including those with chronic pain related to prior cancer or its treatment who do not require frequent opioid dosage escalation.
  • Seven systematic reviews/meta-analyses provided information about Naldemedine and its indication.
  • The studies revealed that Naldemedine has significant effectiveness in treating OIC in cancer populations compared to placebo groups. It also showed superior ability in promoting bowel function when directly compared to other laxatives and PAMORAs such as naloxegol and methylnaltrexone.
  • In terms of the safety profile, Naldemedine presented side effects like diarrhea, abdominal pain, and potential nasopharyngitis but was deemed comparable or favorable to other drugs within its class. For instance, it had preferable outcomes regarding spontaneous bowel movements when compared with naloxegol.
  • One study highlighted magnesium oxide along with Naldemedine as likely effective for preventing OIC among cancer patients undergoing chronic opioid therapy, which can be critical for managing symptoms preemptively within these populations susceptible to such a condition.
  • The studies provided insights into the application of Naldemedine across both cancer and non-cancer patient groups, emphasizing efficacy and manageable side effects, indicating utility across different population subgroups enduring chronic pain. Through comparison between different dosages (0.1 mg, 0.2 mg & 0.4 mg), evidence pointed towards a balance between efficacy and the prevalence of adverse events, guiding on optimal dosing strategies without compromising patient safety; lower doses suggested reduced risk while potentially minimizing severe adverse effects.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines