Drug updated on 9/4/2024
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.
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Summary
- 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 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 |
---|---|---|
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 |