Duloxetine has received approval from the European Medicines Agency (EMEA) to treat diabetic peripheral neuropathic pain (DPNP) in adults - a very severe form of pins and needles from nerve damage caused by high blood-sugar levels.
Have I heard about this drug before?
Probably, because it's the third indication for the drug. Last year, under the brand name Yentreve, it began to be used in the treatment of women with moderate to severe stress urinary incontinence. And, as Cymbalta, it has been available since January to treat depression.
Which firms are behind the drug and what PR have they been doing?
Duloxetine is marketed by Eli Lilly and Boehringer Ingelheim. PR around Yentreve is handled by Red Door Communications but in the UK, at present, the focus for duloxetine is on its newest indication as an antidepressant (Cymbalta), on which Packer Forbes Communications has already been working, explaining the benefits to medical practitioners.
Will either PR agency handle duloxetine in its next indication, too?
No decision has been made about either an agency or a PR strategy - or indeed a brand name - for the drug in its expected new indication. But given the specialist area, and the fact that it will be prescription-only, medical education is likely to be all-important once again.
This sounds a bit sketchy. Is there actually a licence for the new indication?
Not yet. EMEA has issued a 'positive opinion', recommending that the European Commission allows the drug to be marketed for DPNP. That is expected before the end of this year. The drug has been used in the US since 2004 for DPNP and depression.
Is DPNP widespread?
It is thought that between 30 per cent and 60 per cent of Europe's 33 million sufferers may have diabetic neuropathy. Duloxetine is a dual-reuptake inhibitor of serotonin and noradrenaline and works in the new indication by reducing the body's sensation of pain. In trials, patients taking duloxetine showed significant pain reduction - particularly at night, which is important since interfering with sleep is one of the main problems for sufferers.
Further information www.lilly.co.uk.