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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.
Methylnaltrexone bromide · 1 trial · 1 indication
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.
| 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. |
| 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 being studied for opioid-induced constipation, a gastrointestinal condition in which opioid pain medicines slow bowel function. The clinical program has focused on treating this constipation in patients undergoing rehabilitation after orthopedic procedures. It is a small molecule therapeutic candidate rather than a supportive care product.
Methylnaltrexone bromide targets OPRM1, the mu opioid receptor, and acts as an antagonist at that receptor. By blocking mu opioid receptor signaling in the gut, the drug is designed to address opioid-induced constipation without reversing the pain relief opioids provide. This peripheral receptor blockade is the basis of its development in gastrointestinal indications.
Methylnaltrexone bromide is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is the sponsor behind the clinical program evaluating the drug in opioid-induced constipation, including the Phase 2 study conducted in the United States.
Methylnaltrexone bromide is in Phase 2 clinical development for opioid-induced constipation. It is an investigational drug and has not been established as approved for this use based on the development stage reported here. The Phase 2 trial in this program has been completed.
Methylnaltrexone bromide has been evaluated in the Phase 2 trial NCT00640146, titled Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures. That trial enrolled 37 participants in the United States, was randomized, double blind, and placebo controlled, and is now completed.
Methylnaltrexone bromide has been studied in a randomized, double blind, placebo controlled Phase 2 trial of subcutaneous administration for opioid-induced constipation during rehabilitation after orthopedic procedures. The trial enrolled 37 adults aged 18 years and older in the United States and has been completed. No biomarker selection was used in that study.