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J&J's Nucynta tackles pain in people with diabetes

Phase III success in diabetic peripheral neuropathy

Johnson & Johnson's painkiller Nucynta has been shown to provide effective pain relief in diabetic peripheral neuropathy (DPN), a condition which is highly-resistant to conventional analgesics.

The phase III trial carried out by J&J subsidiary Janssen Pharmaceuticals showed that an extended-release formulation of Nucynta (tapentadol) outperformed placebo in providing pain relief to adult patients who had moderate to severe, painful DPN for six months or more, and had already been taking analgesics to try to control it for at least three months.

By the end of the 12-week maintenance portion of the study, treatment with tapentadol ER had cut the intensity of pain in half - from an average of 7.3 to 3.6 on a 10-point scale. Side effects occurred in around 10 per cent of patents, and were mostly opioid-related effects such as nausea, dizziness, constipation and somnolence.

"Painful DPN is a common and burdensome complication of diabetes, and controlling pain in people with DPN can be challenging," said the lead investigator in the study, Aaron Vinik of Eastern Virginia Medical School.

"These data suggest tapentadol ER provides a significant reduction in chronic pain in adult patients with DPN."

The burden of DPN is growing in line with the epidemic of diabetes in the developed world, and clinicians often struggle to manage patients with the condition effectively, relying on not only analgesics but also other drug classes such as anticonvulsants and antidepressants.

Nucynta ER, which was granted FDA approval for the treatment of chronic pain in August last year, has been tipped in some quarters as a potential blockbuster in the overall neuropathic pain market, which includes conditions such as post-herpetic neuralgia and HIV-related neuropathic pain in addition to DPN.

An immediate-release formulation of the drug has been available since 2008, with annual sales running at around $150m last year. The Nucynta franchise had been estimated to reach around $250m this year.

Tapentadol was originally developed by German company Gruenenthal and is the first in a new class of centrally-acting analgesics which work as a mu-opioid receptor agonist and noradrenaline reuptake inhibitor.

18th May 2012

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