Lilly submits Cymbalta sNDA for generalised anxiety disorder
Eli Lilly has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for Cymbalta (duloxetine HCl) for the treatment of generalised anxiety disorder.
Eli Lilly has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for Cymbalta (duloxetine HCl) for the treatment of generalised anxiety disorder.
Cymbalta is already approved in the US for major depressive disorder and the management of diabetic peripheral neuropathic pain in adults. Lilly is also conducting Phase III studies on Cymbalta and its effects on fibromyalgia, a chronic, often debilitating pain disorder characterised by widespread muscle aches, pain and stiffness in muscles, and often accompanied by fatigue and sleep disturbance.
Every year four million Americans aged 18 to 54 are diagnosed with generalised anxiety disorder, the majority of them women. It is common for people with the disorder to experience other physical and mental disorders, including depression, eating disorders or substance abuse.
Disturbances of serotonin and/or norepinephrine may explain the presence of both the emotional and physical symptoms of depression. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine.