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Label indication • RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults 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.
Also known as N-methylnaltrexone bromide (MOA-728), Relistor
N-methylnaltrexone bromide · 3 trials · 1 indication
Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).
A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.
| Arm | Type | Description |
|---|---|---|
| MOA-728 12 mg QD | EXPERIMENTAL | Participants will receive MOA-728 12 milligrams (mg) SC once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day. |
| 1 | PLACEBO_COMPARATOR | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 150 mg | EXPERIMENTAL | - |
| 300 mg | EXPERIMENTAL | - |
| 450 mg | EXPERIMENTAL | - |
| 600 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| N-methylnaltrexone bromide (MOA-728) | DRUG | MOA-728 will be administered as per the dose and schedule specified in the arm. |
| placebo | OTHER | placebo |
Inclusion Criteria: * Men and women 18 years or older. * A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition. * A history of constipation due to opioid use during 1 month before the screening visit. Exclusion Criteria: * A...
N-methylnaltrexone bromide is an investigational small molecule being developed for constipation, including opioid-induced constipation. It is a peripherally restricted opioid receptor antagonist. Bausch Health Companies Inc. (BHC) is developing it, and it has completed Phase 3 clinical trials.
N-methylnaltrexone bromide is being developed for the treatment of constipation, specifically opioid-induced constipation in patients with chronic non-malignant pain. It is an investigational therapy and has not been approved by the FDA for any indication.
N-methylnaltrexone bromide is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is responsible for its clinical development program.
N-methylnaltrexone bromide is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Three trials have been completed, including two Phase 3 studies and one Phase 2 study.
N-methylnaltrexone bromide has been studied in three completed trials: NCT00804141, a Phase 3 long-term safety study in opioid-induced constipation; NCT00547586, a Phase 2 oral study in opioid-induced bowel dysfunction; and NCT00529087, a Phase 3 subcutaneous study in opioid-induced constipation.
Yes, N-methylnaltrexone bromide is also known as MOA-728. MOA-728 is the development code used in clinical trial titles, such as the Phase 3 study NCT00804141 evaluating long-term safety in participants with opioid-induced constipation.