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MOA-728 · 11 trials · 7 indications
Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.
| Arm | Type | Description |
|---|---|---|
| MOA-728 12 mg | EXPERIMENTAL | Participants will receive methylnaltrexone (MOA-728) 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days. |
| MOA-728 24 mg | EXPERIMENTAL | Participants will receive MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days. |
| 150 mg | EXPERIMENTAL | MOA-728 |
| 300 mg | EXPERIMENTAL | MOA-728 |
| 450 mg | EXPERIMENTAL | MOA-728 |
| 600 mg | EXPERIMENTAL | MOA-728 |
| Name | Type | Description |
|---|---|---|
| MOA-728 | DRUG | MOA-728 will be administered per the dose and schedule specified in the arm. |
| Placebo | DRUG | Placebo matching to MOA-728 will be administered per the schedule specified in the arm. |
Inclusion Criteria: * Males and females, ages 18 and older. * Scheduled for ventral wall hernia repair with general anesthesia. * Meets the American Society of Anesthesiologists physical status I, II, or III. Exclusion Criteria: * Received investigational drug or procedure within 30 days of rando...
MOA-728 is an investigational small molecule being studied for postoperative ileus, a condition of slowed or stopped bowel movement after surgery. It has also been evaluated in clinical trials involving healthy subjects and adults on stable methadone maintenance. The drug is not approved and remains in clinical development.
MOA-728 is being developed by Bausch Health Companies Inc., a company traded on the New York Stock Exchange under the ticker BHC. The drug is an investigational small molecule and has not received regulatory approval.
MOA-728 has completed Phase 1 clinical trials, including studies in healthy subjects and methadone-maintenance subjects. A Phase 3 trial evaluating the drug for postoperative ileus after ventral hernia repair has also been completed. The drug remains investigational and is not approved.
MOA-728 has been studied in several completed trials. NCT00387491 was a dose-ranging study in healthy methadone maintenance subjects. NCT00434395 evaluated effects on cardiac repolarization in healthy subjects. NCT00447811 studied subjects on stable methadone maintenance. NCT00528970 was a Phase 3 trial for postoperative ileus after ventral hernia repair.
MOA-728 is the investigational name used in clinical trials for this drug candidate. No alternative names have been established in the public trial record. The drug is a small molecule being developed by Bausch Health Companies Inc.
Yes, MOA-728 was evaluated in a Phase 3 clinical trial (NCT00528970) for the treatment of postoperative ileus in participants after ventral hernia repair. The trial enrolled 374 participants across multiple countries, including the United States, Australia, Belgium, Canada, Germany, Hungary, Italy, Netherlands, Poland, South Africa, and South Korea.