July 23, 2010 -- An extended-release form of the pain medication tapentadol has lower amount of gastrointestinal side effects than oxycodone when taken orally for pain relief in pain clinic patients with chronic low back pain, in a new study results.
The current form of painkiller, called tapentadol ER, provides a new alternative for chronic pain clinic patients if approved by the FDA.
Researchers studied the safety and tolerability of the drug in pain clinic patients with chronic knee or osteoarthritis, compared to patients taking the better known and older oxycodone CR.
The amount of gastrointestinal side effects including constipation, nausea, or vomiting leading to discontinuation in the study was 2.5 times greater in pain clinic patients taking oxycodone than subjects taking tapentadol ER.
Tapentadol ER provided sustained relief of moderate to severe chronic knee or hip osteoarthritis pain or chronic back pain clinic patients for up to a year.
"These study results illustrate the tolerability of tapentadol ER compared with oxycodone CR, a standard chronic pain medication," Brian Moster, MD, wrote,"We are about the encouraged by the distinct possibility of bringing this compound forward to pain patients in the future."
The main reason for the study was to determine the safety of oral tapentadol ER in strengths of 250 milligrams two times a daily over a one-year period and comparing it to oxycodone CR.
The study showed 894 pain clinic 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.
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