Palexia® PR has a well-established safety profile2,3

Individual treatment-emergent adverse events reported in ≥ 5% of patients during the overall treatment period (safety set)2

*In severe chronic low back pain with a neuropathic component.

P values are based on exploratory analyses (safety set).
*P = 0.045 vs. oxycodone + naloxone PR.
§P = 0.036 vs. oxycodone + naloxone PR.
For complete information on adverse events/contraindications/special warnings including respiratory depression please refer to the latest Summary of Product Characteristics
Adapted from Baron R et al. Pain Practice 2016;16(5):600–619.

Adverse drug reactions that were experienced by patients in the placebo controlled trials (in osteoarthritis and chronic low back pain) performed with Palexia® PR were predominantly of mild and moderate severity. The most frequent adverse drug reactions were in the gastrointestinal and central nervous system (nausea, vomiting, somnolence, dizziness and headache).1

In patients with severe chronic low back pain with a neuropathic component, Palexia® PR presented a 40.3% lower incidence of constipation compared with oxycodone+naloxone PR during the titration and overall treatment periods (p≤0.045). Gastrointestinal treatment-emergent adverse events leading to discontinuations was also lower compared with oxycodone+naloxone PR (13.1% Palexia® PR vs 20.3% oxycodone+naloxone PR).2

For further details of the safety profile, please consult the
Palexia® PR Prescribing Information.

Palexia® PR provides superior GI tolerability relative to oxycodone + naloxone PR in severe chronic low back pain2

Gastrointestinal (GI) tolerability can be a common concern when initiating opioid therapy.
Some opioids are known to induce constipation, which often require laxatives, and can
lead to discontinuation of treatment, possibly compromising better patient outcomes.2,4

In severe chronic low back pain patients with a neuropathic pain component,

with Palexia® PR compared with patients on oxycodone + naloxone PR2

Taken from individual treatment-emergent adverse events reported by ≥ 5% of patients in either treatment group during the overall treatment period (safety set).
§P = 0.045 vs. oxycodone + naloxone PR. P values are based on exploratory analyses.
Adapted from Baron et al. Pain Pract. 2016;16(5):600–619.
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