Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Methylnaltrexone bromide · 2 trials · 2 indications
Percentage of participants who had a laxation (that is, bowel movement) within 2 hours after the first dose of study drug, were reported. Participants taking stool softeners within 24 hours of study drug dosing and participants taking rescue laxative medications within 48 hours of study drug dosing were assessed as treatment failures.
Percentage of participants who had a laxation (that is, bowel movement) within 4 hours after the first dose of study drug, were reported. Participants taking stool softeners within 24 hours of study drug dosing and participants taking rescue laxative medications within 48 hours of study drug dosing were assessed as treatment failures.
To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.
| Arm | Type | Description |
|---|---|---|
| MNTX | EXPERIMENTAL | Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) subcutaneously (SC) once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to MNTX SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled. |
| Arm 1 | EXPERIMENTAL | Methylnaltrexone bromide |
| Name | Type | Description |
|---|---|---|
| Methylnaltrexone bromide | DRUG | Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm. |
| Placebo | DRUG | Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm. |
Inclusion Criteria: 1. Male and female participants greater than or equal to (\>=) 18 years of age. 2. Participants must have undergone an orthopedic procedure (that is, total knee or hip replacement, spinal fusion, or reduction of fracture(s) with or without surgical fixation post trauma). 3. Part...
Methylnaltrexone bromide is a small molecule being studied for opioid-induced constipation and in healthy adult subjects. It is administered subcutaneously. The drug is currently in clinical development and is not approved for any use.
Methylnaltrexone bromide is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is conducting clinical trials to evaluate the drug for opioid-induced constipation and in healthy adult subjects.
Methylnaltrexone bromide is in Phase 1 clinical development. It has completed a Phase 1 pharmacokinetic study in healthy adult subjects and a Phase 2 study in patients with opioid-induced constipation. The drug remains investigational.
Methylnaltrexone bromide has been studied in two completed trials. NCT00640146 was a Phase 2 study in opioid-induced constipation during rehabilitation after orthopedic procedures, enrolling 37 participants. NCT01366326 was a Phase 1 pharmacokinetic study in healthy adult subjects, enrolling 20 participants.
Methylnaltrexone bromide is a small molecule that works by targeting opioid receptors in the gut. It is designed to block the constipating effects of opioids without affecting their pain-relieving action, thereby helping to relieve opioid-induced constipation.