Methylnaltrexone, a drug developed to relieve one of the major side effects of pain therapy for cancer patients, received marketing approval from the United States Food and Drug Administration on April 24, 2008, for use in the treatment of opioid-induced bowel disorders in patients receiving palliative care for advanced illness such as cancer.
The FDA's European equivalent, the Committee for Medicinal Products for Human Use, also rendered a "positive opinion" for RELISTOR on April 24. Health Canada, the Canadian Regulatory Agency, approved methylnaltrexone (to be marketed as RELISTOR) on March 28.
"This new drug will be helpful to patients who experience severe constipation associated with the continuous use of morphine or other opioids, which are an important part of care for patients with late-stage, advanced illness," said Joyce Korvick, M.D., deputy director of the Division of Gastroenterology Products at the FDA.
"It took almost 30 years but it finally seems that a very useful drug will at last become an option for those who desperately need it," said Jonathan Moss, M.D., Ph.D., professor of anesthesia & critical care at the University of Chicago Medical Center. "Patients who depend on opiates for pain relief at the end of life are often forced to curtail their opiates because of the side effects. This solves an important clinical problem for some of our most vulnerable patients."
In the United States, powerful opioid-based pain relievers--such as Percocet, OxyContin or morphine--are taken by more than 1.5 million people who suffer from advanced illness such as cancer. Although morphine and related compounds remain the gold standard for pain relief, these drugs often produce significant side effects. One of the most troubling for patients is severe constipation. This can be so distressing that many patients discontinue their pain medication. Methylnaltrexone blocks the side effects without disrupting pain relief.
|Contact: John Easton|
University of Chicago Medical Center