Eli Lilly submits Cymbalta sNDA to US FDA

US drug major Eli Lilly has submitted a supplemental New Drug Application to the US Food and Drug Administration for Cymbalta (duloxetine HCl) for the treatment of generalized anxiety disorder.

Every year four million US citizens ages 18-54 are diagnosed with GAD, the majority of whom are women. It is common for them to also experience other physical and mental disorders, including depression, eating disorders or substance abuse. Because GAD presents with a variety of symptoms, both anxious and physical, it can be difficult to diagnose although, when left untreated, symptoms may get progressively worse, the firm noted.

Cymbalta is already approved in the USA for the treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain, both in adults, but Lilly is also conducting Phase III studies on the agent in fibromyalgia, a chronic, often debilitating pain disorder characterized by widespread muscle aches, pain and stiffness in muscles, and frequently accompanied by fatigue and sleep disturbance.