Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 12.5 mg, 25 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.
Latest News
Summary
- Movantik (naloxegol) 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 five systematic review(s)/meta-analysis(es). [1-5]
- Naloxegol consistently demonstrated higher efficacy than placebo in treating opioid-induced constipation (OIC), with rapid and sustained improvements noted in response rates, spontaneous bowel movements (SBM), and complete SBMs (CSBM) in patients with chronic non-cancer pain and the general population of OIC patients.
- Naldemedine produced more spontaneous bowel movements than naloxegol in the general population of patients with OIC, indicating higher efficacy in this outcome. Naloxegol showed moderate benefit in treating non-opioid-related constipation in cancer patients, with greater effectiveness than lubiprostone and linaclotide.
- Both naloxegol and naldemedine were effective in cancer patients with OIC, but direct comparative effectiveness between the two was not provided. Naloxegol's effectiveness was noted across various subgroups, including cancer patients, chronic non-cancer pain patients, and the general OIC population.
- The most common adverse effect associated with naloxegol and naldemedine was diarrhea, observed consistently across studies in cancer patients and the general population with OIC.
- Naloxegol was associated with a low risk of serious adverse events, similar to other peripherally acting mu-opioid receptor antagonists (PAMORAs), with some reports of central opioid withdrawal and gastrointestinal side effects, including abdominal pain and flatulence.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Movantik (naloxegol) prescribing information. | 2023 | RedHill Biopharma 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 |