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.