Lexapro also approved as maintenance treatment
NEW YORK, N.Y., August 29, 2002 -- Forest Laboratories announced that the FDA has approved new labeling for Lexapro (escitalopram oxalate) as maintenance treatment for patients with major depressive disorder.
Lexapro, a selective serotonin reuptake inhibitor (SSRI), is the single-isomer of Celexa (citalopram HBr).
The long-term efficacy of Lexapro was demonstrated in a placebo-controlled relapse trial. Patients receiving Lexapro experienced a significantly longer time to relapse compared to those receiving placebo. Relapse in depression is defined as the return of the symptoms of depression within four to six months of achieving initial success with antidepressant treatment. Lexapro was approved by the FDA on August 14, 2002 for the treatment of major depressive disorder.
"We are pleased that the FDA has granted Lexapro this additional indication shortly after its approval of Lexapro for the treatment of major depressive disorder," said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories. "Relapse is one of the greatest concerns following successful treatment of depression. The use of Lexapro as maintenance therapy may help people who suffer from depression lead more productive lives."
Lexapro is the product of a relatively new approach that involves the removal of one of two enantiomers from Celexa to create a single-enantiomer drug. Celexa is a racemic mixture of two mirror-image halves called the S- and R-enantiomers. With Lexapro, the R-enantiomer (that does not contribute to Celexa's antidepressant activity) has been removed, leaving only the therapeutically active S-enantiomer.
For more information on Lexapro, visit www.lexapro.com.
Forest Laboratories licensed Lexapro from the Danish pharmaceutical firm H. Lundbeck A/S, which developed both citalopram and escitalopram in Europe.
Source: Forest Laboratories
Posted: August 2002