RELISTOR SUMMARY
Carcinogenesis, Mutagenesis, Impairment of Fertility
RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, a peripherally-acting mu-opioid receptor antagonist, is a sterile, clear and colorless to pale yellow aqueous solution.
RELISTOR is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.
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NEWS HIGHLIGHTSMedia Articles Related to Relistor (Methylnaltrexone Subcutaneous)
Health Tip: Help Control Constipation (HealthDay)
Source: Y! Health Digestive Health News [2009.11.12]
HealthDay - (HealthDay News) -- Constipation occurs when it becomes
difficult or painful to have regular bowel movements. What's "regular"
varies by person, however.
Health Tip: Help Control Constipation
Source: MedicineNet Constipation Specialty [2009.11.12]
Title: Health Tip: Help Control Constipation
Category: Health News
Created: 11/12/2009 8:10:00 AM
Last Editorial Review: 11/12/2009
Ironwood And Forest Announce Positive Linaclotide Results From Two Pivotal Phase 3 Trials In Patients With Chronic Constipation
Source: Irritable-Bowel Syndrome News From Medical News Today [2009.11.04]
Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from two Phase 3 clinical trials assessing the safety and efficacy of once-daily dosing of the investigational drug linaclotide in patients with chronic constipation (CC).
Health Tip: Help Prevent Your Child's Constipation
Source: MedicineNet Constipation Specialty [2009.09.25]
Title: Health Tip: Help Prevent Your Child's Constipation
Category: Health News
Created: 9/25/2009 8:10:00 AM
Last Editorial Review: 9/25/2009
Health Tip: When Constipation Requires a Doctor's Appointment
Source: MedicineNet Laxatives For Constipation Specialty [2009.08.03]
Title: Health Tip: When Constipation Requires a Doctor's Appointment
Category: Health News
Created: 8/1/2009 7:00:00 AM
Last Editorial Review: 8/3/2009
Published Studies Related to Relistor (Methylnaltrexone Subcutaneous)
Methylnaltrexone for treatment of opioid-induced constipation in advanced illness patients. [2009.01]
Methylnaltrexone, a peripheral mu-opioid receptor antagonist with restricted ability to cross the blood-brain barrier, may relieve opioid-induced constipation (OIC) without reversing analgesia. A total of 154 patients with advanced illness and OIC enrolled in a double-blind, randomized, placebo-controlled trial, with optional open-label phases (up to 4 months) in hospice and palliative care centers during 2003-2005...
Methylnaltrexone for opioid-induced constipation in advanced illness. [2008.05.29]
BACKGROUND: Constipation is a distressing side effect of opioid treatment. As a quaternary amine, methylnaltrexone, a mu-opioid-receptor antagonist, has restricted ability to cross the blood-brain barrier. We investigated the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness... CONCLUSIONS: Subcutaneous methylnaltrexone rapidly induced laxation in patients with advanced illness and opioid-induced constipation. Treatment did not appear to affect central analgesia or precipitate opioid withdrawal. (Clinical Trials.gov number, NCT00402038 [ClinicalTrials.gov].). Copyright 2008 Massachusetts Medical Society.
Subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with advanced illness: a double-blind, randomized, parallel group, dose-ranging study. [2008.05]
Methylnaltrexone, a peripherally-acting quaternary opioid antagonist, is an investigational treatment for opioid-induced constipation in patients with advanced illness. This randomized, parallel-group, repeated dose, dose-ranging trial included a double-blind phase for one week followed by an open-label phase for a maximum of three weeks.
Reversal of opioid-induced bladder dysfunction by intravenous naloxone and methylnaltrexone. [2007.07]
Peripheral mechanisms may be involved in opioid actions on the urinary bladder. This double-blind study investigated whether opioid inhibition of bladder function is reversed by methylnaltrexone, a peripheral opioid antagonist.
Methylnaltrexone Treatment of Opioid-Induced Constipation in Patients with Advanced Illness. [2009.08.25]
Methylnaltrexone, a peripherally acting mu-opioid receptor antagonist with restricted ability to cross the blood-brain barrier, reverses opioid-induced constipation (OIC) without affecting analgesia. A double-blind study in patients with advanced illness and OIC demonstrated that methylnaltrexone significantly induced laxation within 4 hours after the first dose compared with placebo...
Clinical Trials Related to Relistor (Methylnaltrexone Subcutaneous)
Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department? [Recruiting]
The investigators want to prove that people WITHOUT advanced cancer who are taking opioid
medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since
the FDA has only approved MNTX for advanced cancer patients, the investigators' research is
investigating how MNTX can work for NON-cancer patients. This research is being conducted to
prove that MNTX can work for non-cancer patients with opioid related constipation.
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects [Recruiting]
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous
(injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related
pain and constipation from taking opioids. The length of participation will be up to 7
weeks.
Study Evaluating the Safety of SC Methylnaltrexone in Treatment of Opioid-Induced Constipation [Recruiting]
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the
safety of methylnaltrexone. This drug will be administered by SC injection and will be
tested in late stage, advanced illness patients who have constipation caused by opioid pain
relievers. This study will last 3 months.
Study Evaluating Subcutaneous MOA-728 For Treatment of Opioid-Induced Constipation in Patients With Advanced Illness [Recruiting]
This study will evaluate the safety and efficacy of a subcutaneous injection of
methylnaltrexone in subjects who have opioid-induced constipation and an advanced illness.
The hypothesis is that methylnaltrexone will be safe and effective in relieving
opioid-induced constipation in these subjects.
Study Evaluating Long-Term Safety of MOA-728 in Subjects With Opioid-Induced Constipation [Recruiting]
This is a one-year study to evaluate the long-term safety and tolerability of the
subcutaneous (just under the skin) injection form of MOA-728 for the treatment of
opioid-induced constipation in subjects with nonmalignant pain. The study consists of a 2
week screening period, a 48 week open-label treatment period and a 2 week follow-up period.
Subjects will need to agree to self-administer subcutaneous injections, complete daily
diaries, and check-in via a daily telephone call during that year-long period.
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