Results of Escitalopram and Celexa(TM) Studies Presented at Major Scientific Conference

Dec 13, 2001, 00:00 ET from Forest Laboratories, Inc.

    NEW YORK, Dec. 13 /PRNewswire/ -- Forest Laboratories, Inc. (NYSE:   FRX)
 announced that clinical study results were presented today at an annual
 meeting of neuropsychopharmacologists, including a trial demonstrating that
 escitalopram helps prevent the relapse of depressive episodes when used as
 maintenance therapy.  Other research presented at the meeting included: a
 pooled analysis of flexible-dose studies demonstrating that patients with
 major depressive disorder treated with either escitalopram or Celexa(TM)
 (citalopram HBr) showed significantly greater improvement than patients
 receiving placebo, and a study demonstrating that Celexa may significantly
 reduce depression in adolescents and children.
     (Photo: )
     Celexa, a selective serotonin reuptake inhibitor (SSRI) for the treatment
 of depression marketed by Forest Laboratories, is the fastest growing SSRI in
 the United States.  Escitalopram, a single isomer derived from Celexa, is an
 investigational SSRI for depression and other disorders.  Forest submitted a
 New Drug Application for escitalopram to the U.S. Food and Drug Administration
 earlier this year.  Escitalopram will be marketed by Forest Laboratories in
 the U.S. under the trade name Lexapro(TM).
     "Forest is committed to the development of effective medications for the
 treatment of depression, and the results of these studies are especially
 encouraging," said Howard Solomon, chairman and chief executive officer,
 Forest Laboratories.
     Escitalopram and Prevention of Relapse
     In a study of patients with major depressive disorder aged 18 to 81 years,
 fewer patients treated with escitalopram relapsed and their time to relapse
 was significantly longer than those receiving placebo.  The risk of relapse
 was shown to be 44 percent lower in patients treated with escitalopram than in
 those treated with placebo.  Escitalopram-treated patients also exhibited
 significantly fewer symptoms of depression during the double-blind phase than
 those patients who received placebo.
     "Individuals with depression face the possibility of relapsing and
 experiencing another depressive episode, even after achieving initial success
 with antidepressant treatment," said Mark Rapaport, M.D., associate professor
 at the University of California San Diego School of Medicine and the study's
 lead investigator.  "This study demonstrates that escitalopram can effectively
 reduce the risk of relapse after an initial response to treatment, allowing
 people with depression to lead more productive lives."
     The study began with an initial eight-week, flexible-dose, open-label
 treatment phase with escitalopram.  Escitalopram was flexibly dosed between
 10 mg and 20 mg per day during this open-label phase.  Patients who were
 classified as responders were then randomly assigned to 36 weeks of
 double-blind, fixed-dose treatment.  Of the 274 patients in the fixed-dose
 treatment phase, 181 patients received escitalopram, and 93 patients received
 placebo.  Patients received the same dose of escitalopram during the fixed-
 dose phase as they had received at the end of the open-label phase.  The
 primary efficacy variable was time to depression relapse from the start of the
 double-blind treatment phase.
     Pooled Analysis of Flexible-Dose Studies
     A pooled analysis of two earlier randomized, double-blind, flexible-dose,
 placebo-controlled studies with a total of 844 patients showed that patients
 with major depressive disorder who were treated with either escitalopram or
 Celexa showed significantly greater improvement than depressed patients
 receiving placebo.  Dosing of escitalopram and Celexa was adjusted as needed
 at specified intervals during the eight-week studies.  Escitalopram was dosed
 at 10 mg or 20 mg per day, with a mean daily dose of 12.6 mg throughout the
 studies; Celexa was dosed at either 20 mg or 40 mg per day with a mean daily
 dose of 25.5 mg throughout the studies.  The analysis showed that escitalopram
 and Celexa were both statistically superior to placebo on all efficacy
 measures.  However, this superiority was demonstrated by escitalopram in the
 first week of treatment and later in the study by Celexa.
     In both studies, escitalopram was well tolerated, with some patients
 experiencing adverse events including headache, nausea, diarrhea, and
 insomnia. Similar to previously reported studies, escitalopram discontinuation
 rates due to adverse events were comparable to placebo.
     Celexa in the Treatment of Pediatric Depression
     Celexa was shown to reduce symptoms of depression in adolescents and
 children with major depressive disorder to a significantly greater extent than
 placebo in a randomized, double-blind, placebo-controlled, flexible-dose study
 of 174 pediatric patients (83 children and 91 adolescents).  Thirty-six
 percent of patients treated with Celexa for eight weeks demonstrated a
 reduction in depressive symptoms compared to 24 percent in the placebo group.
 Symptoms of depression in the Celexa group began to decrease significantly in
 the first week of the study and continued to decrease throughout the study.
 The study also showed that Celexa was well tolerated.  The primary outcome
 measure was the Children's Depression Rating Scale-Revised (CDRS-R), a
 standard diagnostic tool.
     "This study is significant because few studies involving any
 antidepressant have shown efficacy compared to placebo in the treatment of
 depression in children and adolescents," said Karen Dineen Wagner, MD, PhD,
 Department of Psychiatry and Behavioral Sciences, University of Texas Medical
 Branch at Galveston, and the study's lead author.  "Citalopram is now one of
 the few therapies for which we have data showing safety and efficacy for this
     Children in the study were 7 to 11 years old, and adolescents 12 to
 17 years old.  All patients in the treatment arm were given 20 mg per day of
 Celexa at the start of the study.  Investigators had the option to increase
 the dose to 40 mg per day any time after the fourth week.  The mean daily dose
 of Celexa in the final week of the study was 23.3 mg for children and 24.4 mg
 for adolescents.  The rate of discontinuation due to adverse events was
 comparable in the Celexa and placebo groups (5.6 percent vs. 5.9 percent),
 suggesting that Celexa doses of 20 to 40 mg per day were well tolerated by the
 children and adolescents in the study.  The more common side effects
 associated with use of Celexa were nausea, influenza-like symptoms, and
     Celexa is indicated for the treatment of depression in adults over the age
 of 18.  Currently, there are no therapies approved for the treatment of major
 depressive disorders in the pediatric population.  The American Academy of
 Child and Adolescent Psychiatry estimates that 5 percent of the pediatric
 population -- or 3.4 million children and adolescents under the age of
 18 -- suffer from depression.
     About Celexa
     Celexa is currently indicated for the treatment of depression in adults
 aged 18 and older.  Prescribed for more than six million U.S. patients, Celexa
 is the fastest growing antidepressant in the U.S.  Celexa is marketed by
 Forest Laboratories in the U.S.  Celexa has been well tolerated by patients in
 many large-scale clinical trials. The most frequent side effects reported were
 nausea, dry mouth, drowsiness, insomnia, increased sweating, tremor, diarrhea,
 and problems with ejaculation.  Full prescribing information can be found on
 the Internet at
     About Escitalopram: An Isomer of Celexa
     Escitalopram is the product of a relatively new research approach that
 involves the removal of one of two isomers from Celexa to create a
 single-isomer drug.  Celexa is a racemic mixture with two mirror-image halves
 called the S- and R-isomers.  The S-isomer of Celexa (escitalopram) is the
 highly selective active isomer in terms of its contribution to Celexa's
 antidepressant effects. With escitalopram, the R-isomer (that does not
 contribute to Celexa's antidepressant activity) has been removed, leaving only
 the therapeutically active S-isomer.  Moreover, isolation of escitalopram (the
 S-isomer) eliminates any unwanted pharmacological effects associated with
 Celexa's R-isomer.  In three efficacy trials involving more than 1,100
 patients, escitalopram was very well tolerated at doses of 10 and 20 mg per
 day.  Escitalopram dropout rates due to adverse events were comparable to
 placebo in all three studies.
     About Forest Laboratories and Its Products
     Forest Laboratories (NYSE:   FRX) develops, manufactures, and sells ethical
 pharmaceutical products that are used for the treatment of a wide range of
 illnesses.  Forest Laboratories' growing line of products includes: Tiazac(R)
 (diltiazem HCL), a once-daily treatment for angina and hypertension; and
 Aerobid(R) (flunisolide), an inhaled steroid indicated for the treatment of
 asthma.  Besides escitalopram for the treatment of depression and other
 disorders, products in Forest's development pipeline include: memantine for
 Alzheimer's disease and neuropathic pain, lercanidipine for hypertension,
 acamprosate for alcohol dependence, ML3000 for osteoarthritis, dexloxiglumide
 for irritable bowel syndrome, neramexane for various central nervous system
 disorders, siramesine for anxiety, and ALX-0646 for migraine headache.
     The Danish pharmaceutical firm H. Lundbeck A/S developed both citalopram
 and escitalopram.
     Except for the historical information contained herein, this release
 contains forward looking statements that involve a number of risks and
 uncertainties, including the difficulty of predicting FDA approvals,
 acceptance and demand for new pharmaceutical products, the impact of
 competitive products and pricing, the timely development and launch of new
 products, and the risk factors listed from time to time in the Company's SEC
 reports, including the Company's Annual Report on Form 10-K for the fiscal
 year ended March 31, 2001 and the quarterly report on Form 10-Q for the
 periods ended June 30, 2001 and September 2001.
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SOURCE Forest Laboratories, Inc.