Drug updated on 4/17/2024
| Dosage Form | Tablet (oral: 0.2 mg) |
| Drug Class | Opioid antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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
- Naldemedine (Symproic) is used 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.
- A total of 7 systematic reviews and meta-analyses were reviewed which provided information on the efficacy and safety of naldemedine in treating opioid-induced constipation.
- In a case-series study involving critically ill patients, primarily diagnosed with COVID-19 ARDS, naldemedine was found safe and associated with reduced gastric residuals promoting laxation after failure of local laxation protocol.
- According to a network meta-analysis comparing available interventions for OIC management, subcutaneous methyl naltrexone performed better than other interventions including naldemedine; however, it should be noted that quality evidence supporting this comparison was either low or very low.
- Another network meta-analysis suggested naloxone as most efficacious treatments for OIC followed by Naldemadine (Symproic), but highlighted naloxone as safer among these agents based on adverse events reported during trials.
- Despite some studies suggesting higher incidence rates of serious adverse effects especially in cancer patient subgroup treated with Symproic compared to placebo group; overall findings from multiple randomized clinical trials indicate that side effects experienced by participants using Symproic are mild to moderate and well tolerated during treatment period.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Symproic (Naldemedine) Prescribing Information. | 2020 | BioDelivery Sciences International, Inc., Raleigh, NC |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation. | 2019 | Gastroenterology |