Grunenthal debuts novel severe pain drug Palexia SR in UK

Family-owned German drugmaker Grunenthal has today launched Palexia SR (tapentadol prolonged release) for the oral treatment of adults with severe chronic pain, which can only be adequately managed with opioid analgesics. Palexia SR is the first in a new class of centrally acting analgesics called MOR-NRI, which has two mechanisms of action in one molecule; both mu-opioid receptor (MOR) agonism and noradrenaline reuptake inhibition (NRI).

In pivotal Phase III trials, Palexia SR demonstrated comparable analgesic efficacy to oxycodone CR and, importantly, superior gastrointestinal tolerability (constipation, nausea and vomiting) (p<0.001) and significantly fewer discontinuations (43.5%) compared with oxycodone CR (61.7%). Patients were able to stay on Palexia SR for a median of 118 days compared to 39 days with oxycodone SR, and superior quality of life outcomes were reported by patients administered Palexia SR, when compared with those in the oxycodone CR arm.

Commenting on the launch, Richard Langford, Consultant in Anesthesia and Pain Medicine at St Bartholomew’s Hospital, London, said: “The introduction of a new medication which combines effective pain relief and the potential for reduced side effects is a welcome addition for clinicians and patients alike. Palexia SR represents a significant advance which can enable a greater proportion of patients with chronic pain to stay on treatment for as long as is required; consequently improving their quality of life.”