Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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, specifically opioid-induced constipation in patients with chronic non-malignant pain. It is being studied as a treatment to address this gastrointestinal condition.
N-methylnaltrexone bromide is being developed by Bausch Health Companies Inc., a company listed on the stock exchange under the ticker symbol BHC. The company is conducting clinical trials to evaluate the drug's safety and efficacy for constipation.
N-methylnaltrexone bromide is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating constipation.
N-methylnaltrexone bromide has been studied in three completed clinical trials. These include NCT00529087, a Phase 3 study of subcutaneous administration in 460 patients; NCT00547586, a Phase 2 study of oral administration in 122 patients; and NCT00804141, a long-term safety study in 1040 patients.
Yes, N-methylnaltrexone bromide is also known as MOA-728. Clinical trial records refer to the drug by this alternative name, and both names are used to describe the same investigational compound being developed for constipation.