Drug updated on 4/16/2024
| 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.
Summary
- Naloxegol (Movantik) is a peripherally acting μ-opioid receptor antagonist (PAMORA) 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.
- Five studies provided information on the effectiveness and safety profile of naloxegol compared to other PAMORAs such as naldemedine and alvimopan.
- In managing opioid-induced constipation in patients with chronic non-cancer pain, naloxegol has shown significantly higher response rates and improvements in symptoms compared to placebo, demonstrating rapid relief from symptoms over a 12-week period.
- Compared to other PAMORAs like naldemedine and alvimopan, naloxegol presented a favorable profile, particularly concerning spontaneous bowel movements (SBMs) and complete spontaneous bowel movements (CSBMs). All PAMORAs were found superior to placebo in reducing opioid-induced constipation, but naloxegol was highlighted as an optimal choice based on available data.
- For cancer patients specifically, while studies lacked sufficient enrollment, observational data suggest that it may improve quality of life. The safety profile observed was similar to that seen in non-cancer populations, with diarrhea being the most common side effect reported within the first week of treatment, which aligns with adverse events noted for other PAMORAs affecting predominantly the gastrointestinal tract.
- When comparing methylnaltrexone, mainly studied subcutaneously administered formulation, against orally administered Movantik (naloxegol), both showed similarly rapid onset action towards reducing opioid-induced constipation symptoms, but oral administration offers a convenience advantage.
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 |