Eli Lilly and Company and Boehringer Ingelheim announced today that Cymbalta/Xeristar (duloxetine hydrochloride)(+) has been granted marketing authorization by the European Commission for the treatment of major depressive episodes.
Cymbalta/Xeristar, a balanced dual-reuptake inhibitor of serotonin and noradrenaline (norepinephrine), has been studied in more than 6,000 adults with major depression worldwide. Safety and efficacy have been demonstrated in four positive acute placebo-controlled clinical trials and a relapse prevention study.
"This is a significant breakthrough as clinical trials show Cymbalta to be a very effective antidepressant," said Robert Peveler, MA, DPhil, FRCPsych, Professor of Psychiatry at the University of Southampton, United Kingdom. "And, unfortunately, there are still a significant number of people suffering from depression in Europe despite the advances in modern medicine."
Researchers believe Cymbalta/Xeristar is effective in treating the emotional and somatic symptoms of depression due to its dual action on two key neurotransmitters, serotonin and noradrenaline. These neurotransmitters are believed to help regulate emotions and sensitivity to pain. Scientists believe that if these neurotransmitters are out of balance, a person may become depressed and be more likely to feel emotional and somatic symptoms. The combination of emotional and somatic symptoms of depression can have a tremendous negative impact on a person's quality of life.
Emotional symptoms include sadness, anxiety, low mood and hopelessness. Somatic symptoms can include fatigue, vague aches and pains, and shoulder, neck and back pain.
"The approval of Cymbalta/Xeristar in the European Union is a major step forward in giving healthcare professionals and patients in all major European countries a long-awaited efficient and well-tolerated new option for treating the full spectrum of symptoms of depression," said Dr. Andreas Barner, member of the Board of Managing Directors and Head of Research, Development and Medicine at Boehringer Ingelheim.
"This is a breakthrough, born out of decades of investment and experience in neuroscience," added Rich Pilnik, President of European Operations at Eli Lilly and Company. "We are pleased to soon make Cymbalta available to patients in Europe because it brings to life our commitment to make a positive impact in the lives of patients."
In Europe alone, an estimated 60 million people suffer from depression. More than 40 per cent of those fail to receive any treatment and only 25-35 per cent of patients treated for depression in clinical studies experience remission or relief from all of their disease symptoms. Experts agree that failure to achieve remission can lead to a greater risk of relapse, continued impairment at work and in social functioning, increased utilization of medical services, and sustained elevation of suicide and substance abuse risks.