Eli Lilly and German partner, Boehringer Ingelheim, are celebrating after have won the backing of the European advisory panel, the CHMP, for duloxetine in the treatment of adults with diabetic peripheral neuropathic pain – a notoriously hard-to-treat condition in which high blood glucose levels cause nerve damage. This is the last hurdle the drug, which is expected to be a major growth driver for the US company [[10/12/04b]], must cross on its route to winning final European clearance – a regulatory decision generally follows a panel recommendation within three months.
The CHMP’s decision was based on a data package including the results of two clinical trials in 791 adults who had the disorder for at least six months. In both studies, duloxetine significantly reduced 24-hour average pain, compared to placebo, with improvements noted as early as the first week of treatment, continuing for the duration of the trial. In addition, duloxetine showed rapid onset of action and effect in reducing pain caused by diabetic neuropathy, and was effective in relieving pain at night.
If the European Commission does approve duloxetine to treat diabetic peripheral neuropathic pain – a condition affecting up to 60% of Europe’s 33 million diabetes patients – it will be the drug’s third indication. The product won the European green light in August last year under the brand names Yentreve and AriClaim for the treatment of stress urinary incontinence [[13/08/04a]], and was again approved in December under the brand names Cymbalta and Xeristar for major depressive episodes [[05/01/05b]].