Treating Pain Effectively - New Study Results Confirm Improved Gastrointestinal Tolerability Of Tapentadol

Results from two phase III clinical studies of tapentadol immediate
release tablets (IR) suggest a significantly improved gastrointestinal
tolerability(1) as well as safety(2) profile compared to oxycodone HCl IR.
The data were presented by the German pharmaceutical company Grunenthal at
this year's Annual Congress of the European League against Rheumatism (EULAR,
June 11-14, Paris, France).





In Europe, one in five adults experiences chronic pain(3) in their life.
To reduce pain effectively, especially with chronic pain conditions, the use
of strong analgesics such as opioids is expanding.(4) However, a substantial
number of patients receiving pain therapy do not feel satisfied with their
treatment(5),(6),(7) and stop their opioid therapy against medical
recommendation.(8) The most important reasons for this are gastrointestinal
(GI) side effects like nausea and vomiting in the first few days and
constipation in the course of ongoing treatment(9); GI tolerability is one of
the leading causes of treatment discontinuation for patients who take
prescription pain medications.





Tapentadol is a novel centrally acting analgesic that acts by two
mechanisms of action, combining mu-opioid receptor agonism and noradrenaline
reuptake inhibition properties in a single molecule. New results from two
phase III studies with tapentadol were presented at the EULAR meeting. A
study in patients with end-stage joint disease showed that treatment with a
50 mg or 75 mg tapentadol IR resulted in significantly higher pain relief
compared to placebo (P










While in the oxycodone HCl IR 10 mg group the discontinuation rate was 29
percent, only 13 and 18 percent of the patients in the tapentadol IR 50- and
75 mg group, respectively, discontinued the treatment before the end of the
study.





The second study presented at the EULAR congress further demonstrates the
improved tolerability profile of tapentadol IR in comparison to oxycodone HCl
IR; for the first time data was collected over a treatment period of 90
days.(2)





The objective of this phase III, randomized 4:1 vs. oxycodone IR,
double-blind, flexible dose study was to assess the safety of tapentadol IR
for treating low back pain or osteoarthritis pain of the hip or knee over a
period of 90 days. Treatment included tapentadol IR (50 or 100 mg) every four
to six hours as needed up to 600 mg per day or oxycodone HCl IR (10 or 15 mg)
every four to six hours as needed up to 90 mg per day. A total of 679 and 170
patients in the tapentadol IR and oxycodone HCl IR groups, with average pain
intensity at inclusion on an 11-point numerical rating scale of 7.0 and 7.2,
respectively(10), were included in the efficacy and safety analyses.





Both treatment groups indicated a comparable analgesic effect at the
specified doses. The incidences of nausea, vomiting, constipation, and the
composite of nausea and/or vomiting in the tapentadol IR group were
significantly lower than in the oxycodone HCl IR group (P