GSK'S Lamictal Filed With FDA For First-Ever Indication In Long-Term Management of Depressive Episodes In Bipolar I Disorder; An Unmet Medical Need Exists For Bipolar Depression.

RESEARCH TRIANGLE PARK, N.C. -- GlaxoSmithKline (GSK) announced today it is seeking the first-ever indication for long-term management of bipolar I disorder to delay the relapse/recurrence of depressive episodes. GSK filed a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Lamictal(R) (lamotrigine).

An estimated 2.3 million American adults have bipolar disorder(1) (also known as manic-depression). The depressive phase of bipolar disorder, often referred to as bipolar depression, is a serious condition that puts people at significant risk for suicide and other harmful behaviors. In fact, approximately 1 in 5 people with bipolar disorder attempt suicide, typically during a depressed or mixed (depression and mania) episode.(2)

"Many effective treatments are available for the acute mania associated with bipolar disorder, but with no approved long-term treatments to delay bipolar depression, there is a critical unmet need for people facing the devastating lows of this illness," said Robert Leadbetter, M.D., director of Psychiatry Clinical Development and Medical Affairs at GlaxoSmithKline. "This filing signals our confidence in Lamictal as a potential treatment option for the millions of…