July 23, 2010 -- An extended-release form of the pain medication tapentadol has fewer gastrointestinal side effects than oxycodone when it's used for pain relief in people with osteoarthritis or chronic low back pain, a new study shows.
The painkiller, called tapentadol ER, could provide a new alternative for the relief of chronic pain if approved by the FDA.
Researchers say they examined the safety and tolerability of the drug in people with chronic knee or hip osteoarthritis pain or pain in the lower back, compared to people taking the better known and older oxycodone CR.
The study, published in the journal Pain Practice, shows that tapentadol ER is associated with a lower overall incidence of adverse gastrointestinal problems than oxycodone CR. Fewer patients taking tapentadol ER tablets suffered constipation, nausea, and bouts of vomiting than people on oxycodone, the study shows.
The incidence of gastrointestinal side effects including constipation, nausea, or vomiting leading to discontinuation in the study was 2.5 times greater in patients taking oxycodone than those taking tapentadol ER, researchers say.
"We are encouraged by these study results as they illustrate the tolerability of tapentadol ER compared with oxycodone CR, a standard chronic pain treatment," Bruce Moskovitz, MD, of Ortho-McNeil Janssen Scientific Affairs, says in a news release. "We are pleased about the possibility of bringing this important investigational compound forward to patients in the future."
Comparing Side Effects
The objective of the study was to determine the safety of taking tapentadol ER in strengths of 100 milligrams to 250 milligrams two times a day over a one-year period and comparing its effectiveness and safety to oxycodone CR.
The researchers say 894 patients took tapentadol ER and 223 oxycodone. The overall incidence of patients having at least one adverse gastrointestinal event was 85.7% in the tapentadol ER group, compared to 90.6% in those taking oxycodone CR.
In developed countries, chronic low back pain is the most common cause of disability.
Researchers say that extended-release opioid painkillers have been shown to provide relief for people with moderate to severe pain, but many are associated with high incidences of gastrointestinal problems.
"The favorable gastrointestinal tolerability profile observed for tapentadol ER over the one-year treatment period may improve patient compliance with long-term analgesic treatment," the researchers write.
Tapentadol is a product of Johnson & Johnson Pharmaceutical Research and Development in Raritan, N.J., and Grunenthal GmbH of Aachen, Germany, which conducted the study.
An immediate-release form of tapentadol, called Nucynta, was approved by the FDA in November 2008. Johnson & Johnson has asked the FDA to approve the extended release formulation of the drug.