Cymbalta approved for second indication
pharmafile | February 24, 2005 | News story | Sales and Marketing |
Cymbalta has received European approval for diabetic peripheral neuropathic pain (DPNP) in adults, with its marketers keen to meet what it says is unmet demand from sufferers in Europe.
More than 33 million patients in Europe have diabetes and it is believed that 30-60% of these may have diabetic neuropathy.
The drug, tipped to earn $2 billion by 2008, was launched last year in the US for the treatment of diabetic peripheral neuropathic pain and depression, recording sales of around $93 million.
Marketed by Eli Lilly and Boehringer Ingelheim across the European Union, Cymbalta (duloxetine) is a dual-reuptake inhibitor of serotonin and noradrenaline and works in the new indication by reducing the body's sensation of pain from the nerve damage caused by diabetes.
Its latest approval for DPNP was based on data from two randomised 12-week trials involving nearly 800 patients.
Patients taking duloxetine showed a reduction in pain caused by diabetic neuropathy at 60mg and 120mg doses, as well as relieving pain at night – a major irritant for patients with diabetic neuropathy as it can interfere with sleep.
The patients, on average, were 60 years old, suffered from diabetes for 11 years and from diabetic neuropathy for four years, and rated their pain as moderate to moderately severe.
The European Medicines Agency (EMEA) has approved duloxetine for three indications in under a year. It was approved as Yentreve in August 2004 for the treatment of moderate-to-severe stress urinary incontinence (SUI) in women and in December, as Cymbalta, for major depressive episodes.
The FDA recently refused to approve Yentreve because of the data package submitted, but declined to indicate whether the shortcomings related to particular safety or efficacy problems.