Efficacy of Tapentadol ER for Managing
Moderate to Severe Chronic Pain
Authors: Afilalo Marc 
Published: February 2021

Background: Chronic non–cancer-related pain affects a large proportion of the adult population
and is often difficult to manage effectively. Although opioid analgesics have been used to relieve
chronic pain of different etiologies, opioids are associated with a range of side effects that
may reduce patient quality of life and lead to reduced compliance with treatment.Tapentadol
is a centrally acting analgesic with 2 mechanisms of action, µ-opioid receptor agonism and
norepinephrine reuptake inhibition, that is available in an extended-release formulation for the
management of chronic pain.
Objective: To review the efficacy of tapentadol extended release (ER) for the management of
moderate to severe chronic nociceptive and neuropathic pain.
Methods: Efficacy results are summarized for four 15-week phase 3 studies of tapentadol ER
in patients with moderate to severe chronic osteoarthritis knee pain (2 studies; ClinicalTrials.gov
Identifiers: NCT00421928 and NCT00486811), low back pain (NCT00449176), and pain related to
diabetic peripheral neuropathy (DPN; NCT00455520); a one-year phase 3 study of tapentadol ER in
patients with moderate to severe chronic osteoarthritis pain or low back pain (NCT00361504); and
a pooled analysis of data from the 15-week studies in patients with osteoarthritis knee pain or low
back pain. A summary of the comparative tolerability for tapentadol ER and the active comparator
used in these studies, oxycodone controlled release (CR), is provided.
Results: Results of these studies showed that tapentadol ER (100 - 250 mg bid) was effective
for the management of moderate to severe chronic osteoarthritis knee pain, low back pain, and
pain related to DPN. Tapentadol ER (100 - 250 mg bid) has been shown to provide comparable
pain relief to oxycodone HCl CR (20 - 50 mg bid) for chronic osteoarthritis knee pain and low back
pain over up to one year of treatment. Tapentadol ER (100 - 250 mg bid) was associated with an
improved tolerability profile, particularly gastrointestinal tolerability profile, and with lower rates of
treatment discontinuations and adverse event-related discontinuations compared with oxycodone
HCl CR (50 - 250 mg bid) over up to one year of treatment in patients with osteoarthritis knee
pain and low back pain.
Limitations: Differences in the design and duration of these phase 3 studies may limit
comparisons of the efficacy results; nevertheless, this summary of efficacy results demonstrates the
broad efficacy of tapentadol ER for different types of nociceptive and neuropathic pain.
Conclusions: Tapentadol ER (100 - 250 mg bid) is effective for moderate to severe osteoarthritis
pain, low back pain, and pain related to DPN and provides efficacy similar to that of oxycodone HCl
CR (20 - 50 mg bid) for patients with osteoarthritis and low back pain. Tapentadol ER treatment
has been associated with better gastrointestinal tolerability and compliance with therapy than
oxycodone CR, which suggests that tapentadol ER may be a better option for the long-term
management of chronic pain.
Key words: Chronic pain, tapentadol ER, osteoarthritis pain, low back pain, diabetic peripheral
neuropathy, oxycodone CR, opioid, analgesic