FDA Okays Methylnaltrexone Bromide (Relistor) for Opioid-Induced Constipation
By Peggy Peck
26 april 2008-- The FDA has approved methylnaltrexone bromide (Relistor) injection for treatment of opioid-induced constipation, a common condition among patients on continuous medication for pain relief in late-stage illness.
Opioids interfere with normal bowel function by relaxing intestinal smooth muscle cells, which prevents the intestine from contracting normally. Methylnaltrexone bromide blocks opioid receptors on the intestinal muscle cells thus allowing the bowels to function normally.
The FDA approval was based on two randomized, double-blind placebo-controlled studies involving 287 participants and conducted over four months.
The median age of study participants was 68; 51% were women.
All patients had advanced late-stage illnesses with a life expectancy of less than six months. Participants had had either fewer than three bowel movements in the week before treatment or no bowel movement for more than two days.
The FDA said patients who were treated with methylnaltrexone bromide had a significantly higher rate of elimination than those receiving placebo.
Methlynaltrexone bromide is an injectable medication that can be administered as needed, but not more than once in a 24-hour period.
The recommended dose is 8 mg for patients weighing 38 to less than 61 kg (84 to less than 135 lb) or 12 mg for patients weighing 62 to 114 kg (136 to 251 lb). Patients whose weights fall outside those ranges should be dosed at 0.15 mg/kg.
The recommended starting schedule is one dose every other day as needed for patients with late-stage advanced illness.
The drug is not recommended for patients with known or suspected intestinal obstructions.
Common side effects included abdominal pain, gas, nausea, dizziness, and diarrhea. The safety and effectiveness of methylnaltrexone bromide have not been studied in pediatric populations.
Methlynaltrexone bromide is manufactured by Wyeth Pharmaceuticals Inc., in Philadelphia, and Progenics Pharmaceuticals in Tarrytown, N.Y.
By Peggy Peck
26 april 2008-- The FDA has approved methylnaltrexone bromide (Relistor) injection for treatment of opioid-induced constipation, a common condition among patients on continuous medication for pain relief in late-stage illness.
Opioids interfere with normal bowel function by relaxing intestinal smooth muscle cells, which prevents the intestine from contracting normally. Methylnaltrexone bromide blocks opioid receptors on the intestinal muscle cells thus allowing the bowels to function normally.
The FDA approval was based on two randomized, double-blind placebo-controlled studies involving 287 participants and conducted over four months.
The median age of study participants was 68; 51% were women.
All patients had advanced late-stage illnesses with a life expectancy of less than six months. Participants had had either fewer than three bowel movements in the week before treatment or no bowel movement for more than two days.
The FDA said patients who were treated with methylnaltrexone bromide had a significantly higher rate of elimination than those receiving placebo.
Methlynaltrexone bromide is an injectable medication that can be administered as needed, but not more than once in a 24-hour period.
The recommended dose is 8 mg for patients weighing 38 to less than 61 kg (84 to less than 135 lb) or 12 mg for patients weighing 62 to 114 kg (136 to 251 lb). Patients whose weights fall outside those ranges should be dosed at 0.15 mg/kg.
The recommended starting schedule is one dose every other day as needed for patients with late-stage advanced illness.
The drug is not recommended for patients with known or suspected intestinal obstructions.
Common side effects included abdominal pain, gas, nausea, dizziness, and diarrhea. The safety and effectiveness of methylnaltrexone bromide have not been studied in pediatric populations.
Methlynaltrexone bromide is manufactured by Wyeth Pharmaceuticals Inc., in Philadelphia, and Progenics Pharmaceuticals in Tarrytown, N.Y.
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