NEW YORK, December 18 - Forest Laboratories, Inc. (NYSE:FRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Lexapro (escitalopram oxalate), a selective serotonin reuptake inhibitor (SSRI), for the treatment of generalized anxiety disorder (GAD), a condition that affects approximately four million Americans annually. The new indication is based on three studies, all of which were positive and support the efficacy and safety of Lexapro in the treatment of GAD. GAD is characterized by excessive anxiety and worry that significantly impacts an individual's daily functioning. Lexapro is also indicated for the initial treatment and maintenance of major depressive disorder.

"One of the biggest challenges in treating GAD patients is finding a treatment that is not only effective, but also one that patients will be able to tolerate for the long term," said Philip Ninan, M.D., professor of Psychiatry and Behavioral Sciences and director of the Mood and Anxiety Disorders Program at Emory University School of Medicine. "Lexapro is a first-line treatment option, which has proven to be effective with a favorable side effect profile."

Study Details

All three studies that support the indication approval were randomized, double-blind, eight weeks in duration and placebo-controlled. The studies involved approximately 850 patients, 18 to 80 years of age, diagnosed with GAD. Patients in the Lexapro arm were administered a fixed dose of 10 mg per day for the first four weeks and then flexibly dosed to a maximum of 20 mg per day. The Hamilton Anxiety Scale (HAMA) total score was the primary efficacy variable, and secondary efficacy measures included changes in HAMA psychic anxiety subscale and Clinical Global Impressions (CGI) scores. In each of the three studies, Lexapro 10 to 20 mg per day significantly improved GAD symptoms in patients compared to placebo as measured by change from baseline in HAMA score. By-visit anal
'"/>

Contact: Charles E. Triano
212-224-6714
Forest Laboratories
18-Dec-2003

Page: 1 2
Related medicine news :

1. Starting dose of Lexapro as effective as optimally dosed Zoloft in the treatment of depression
2. UIC professor receives international humanitarian award
3. Mailman School of Public Health receives Manhattan Tobacco Cessation Center grant
4. Epidemiologist Trichopoulos receives $5.8 million Department of Defense Innovator Award
5. GlaxoSmithKline receives unanimous favorable recommendation by FDA Advisory Committee for Boostrix
6. NYU Child Study Center receives grant from the American Red Cross September 11 recovery program
7. Northwestern Memorial Hospital receives $10 million commitment to support preeminent heart program
8. American Academy of Neurology program receives Grassroots Award
9. Orqis receives FDA approval to expand clinical trial of Cancion CRS therapy to 40 centers
10. Mayo Clinic Cancer Center receives SPORE grant for brain cancer research from NCI
11. Pfizers antifungal medicine VFEND receives FDA approval