NEW YORK, Nov. 29 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) and H. Lundbeck A/S today announced preliminary top-line results
from a phase III study of LEXAPRO (escitalopram oxalate) in the treatment of
adolescents, aged 12-17, with Major Depressive Disorder (MDD). These results
indicate that patients treated with LEXAPRO experienced statistically
significant improvement in symptoms of depression, as measured by the study's
primary endpoint, the Children's Depression Rating Scale-Revised (CDRS-R),
compared to placebo. The CDRS-R is a commonly used clinician-rated instrument
that covers 17 symptom areas of depression relevant to adolescents, including
impaired schoolwork, difficulty having fun, social withdrawal, physical
complaints, and low self-esteem. Additional data from this study are expected
to be presented in 2008.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Researchers estimate that up to eight percent of adolescents are affected
by depression.(1) However, FDA-approved treatment options for this population
are limited. LEXAPRO is not currently approved by the FDA for use in
pediatric patients.
"Depression is a significant problem among adolescents, and frequently
goes under-recognized and under-treated in this age group. These data support
that LEXAPRO has potential as an effective treatment option for adolescents
with depression," said Ivan Gergel, M.D., Senior Vice President of Scientific
Affairs and President of the Forest Research Institute.
About the Study
A double-blind, parallel-group, placebo-controlled phase III study to
evaluate the safety and efficacy of LEXAPRO in the treatment of depressed
adolescents, aged 12-17, was conducted in multiple centers across the U.S.
During the eight week study, 316 patients were randomized to receive either
LEXAPRO 10-20 mg (n=158) or placebo (n=158). The primary endpoint was change
from baseline to Week 8 on the Children's Depression Rating Scale - Revised
(CDRS-R) using last observation carried forward (LOCF) approach. The study
showed statistically significant improvement in patients treated with LEXAPRO
relative to placebo (p=0.022).
The trial also showed that LEXAPRO was generally well-tolerated. Overall
premature discontinuation rates (all causes including adverse events) were
[19%] for patients receiving LEXAPRO and [15%] for patients receiving placebo.
Future Development Plans
"Based on these positive results and results of other studies, we see
potential for LEXAPRO, already established as an effective treatment for
adults with depression, as a treatment for adolescents with MDD. Subject to
ongoing communication with the FDA and our review of the full study results
for the just completed trial, we intend to file in 2008 for an adolescent
depression indication for LEXAPRO," said Ivan Gergel, M.D.
Depression and Adolescents
Adolescent depression is characterized by persistent sadness and loss of
interest in usual activities.(3) While the brain chemistry of depression is
not fully understood,(4) research suggests that depression is caused by an
imbalance of certain chemicals in the brain, most notably serotonin.(5)
Despite advances and progress in identifying and treating mental disorders
in adolescents, epidemiologic studies indicate that only 20-35 percent of
depressed patients in this age group currently receive treatment.(6)
Depression is a chronic disease(3) that requires medical attention and
treatment, and if left untreated, may have serious consequences.(7)
For adolescents who suffer from depression, psychotherapy, cognitive-
behavior therapy, interpersonal therapy and medication play an important role
in the management of their illness.(2) Patients on antidepressant treatment
should also be closely monitored by healthcare providers, family members and
other caregivers.
About LEXAPRO
LEXAPRO is an SSRI being studied as a treatment for adolescents with MDD.
LEXAPRO is indicated for the initial and maintenance treatment of major
depressive disorder and generalized anxiety disorder (GAD) in adults. LEXAPRO
is thought to work by helping to restore the brain's chemical balance. It is
believed to increase the availability of serotonin, a substance in the brain
believed to influence mood. In adults, LEXAPRO 10 mg/day is a well-tolerated
therapy, with drop-out rates due to adverse events comparable to placebo in
depression and low in the treatment of GAD. LEXAPRO has been prescribed to
over 16 million people.(11)
Important LEXAPRO Information
Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Antidepressants increased
the risk of suicidality (suicidal thinking and behavior) in children,
adolescents, and young adults in short-term studies in Major Depressive
Disorder (MDD) and other psychiatric disorders. Anyone considering the use of
antidepressants in children, adolescents, or young adults must balance the
risk to clinical need. Patients of all ages started on antidepressant therapy
should be closely monitored and observed for clinical worsening, suicidality,
or unusual changes in behavior, especially at the beginning of therapy or at
the time of dose changes. This risk may persist until significant remission
occurs. Families and caregivers should be advised of the need for close
observation and communication with the prescriber. LEXAPRO is not approved
for use in pediatric patients.
LEXAPRO is contraindicated in patients taking monoamine oxidase inhibitors
(MAOIs), pimozide, or in patients with a hypersensitivity to escitalopram
oxalate. As with other SSRIs, caution is indicated in the coadministration of
tricyclic antidepressants (TCAs) with LEXAPRO. As with other psychotropic
drugs that interfere with serotonin reuptake, patients should be cautioned
regarding the risk of bleeding associated with the concomitant use of LEXAPRO
with NSAIDs, aspirin, or other drugs that affect coagulation. The most common
adverse events reported with LEXAPRO vs placebo (approximately 5 percent or
greater and approximately twice that of placebo) were nausea, insomnia,
ejaculation disorder, somnolence, increased sweating, fatigue, decreased
libido, and anorgasmia. Further information on LEXAPRO is provided in the FDA
approved Package Insert.
About Forest Laboratories and Its Products
Forest Laboratories (www.frx.com) is a U.S.-based pharmaceutical company
dedicated to identifying, developing and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes LEXAPRO(R) (escitalopram oxalate), an SSRI indicated for adults
for the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl D-
aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate
to severe Alzheimer's disease; and Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are abstinent
at treatment initiation. In addition to our growing product line, Forest also
co-promotes the Daiichi Sankyo, Inc. products Benicar(R)* (olmesartan
medoxomil), an angiotensin receptor blocker, Benicar HCT(R)* (olmesartan
medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic
combination product, and AZOR(TM)* (amlodipine and olmesartan medoxomil) a
calcium channel blocker and angiotensin receptor blocker combination product,
all indicated for the treatment of hypertension.
*Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are
registered trademarks of Daiichi Sankyo, Inc.; and Campral is a registered
trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform act of 1995. These statements involve a number of
risks and uncertainties, including the difficulty of predicting FDA approvals,
the 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 form time to time in the Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings.
1. Jellinek MS, Snyder JB. Depression and suicide in children and
adolescents. Pediatr Rev 1998;19: 255-64. Birmaher B, Brent D, et al.
Practice parameters for the assessment and treatment of children and
adolescents with depressive disorders. J Am Acad Child Adolesc
Psychiatry. 1998;37(suppl 10):63S-82S.Note: securing primary source
2. Bhatia, MD S.K., Bhatia, MD S.C., Childhood and Adolescent Depression.
American Family Physician. 2007:Volume 75, Number 1
3. National Institute of Mental Health. Depression. Accessed November 1,
2007, at http://www.nimh.nih.gov/health/topics/depression/index.shtml
4. Mayo Clinic. Depression. Accessed November 1, 2007, at
http://www.mayoclinic.com/health/depression/DS00175/DSECTION=3Paragraph2
5. Mayo Clinic. Depression. Accessed November 1, 2007, at
http://www.mayoclinic.com/health/depression/DS00175/DSECTION=3Paragraph 1
6. Burns BJ, Costello EJ, Angold A, et al. Children's mental health
service use across service sectors. Health Aff (Millwood).1995;14:147-
159. Leaf PJ, Alegria M, Cohen P, et al. Mental health service use in
the community and schools: results from the four-community MECA Study.
Methods for the Epidemiology of Child and Adolescent Mental Disorders
Study. J Am Acad Child Adolesc Psychiatry. 1996;889-897. Note:
securing primary source
7. Mayo Clinic. Depression. Accessed November 1, 2007, at
http://www.mayoclinic.com/health/depression/DS00175/DSECTION=7
Complications section, Paragraph 1
8. Grunbaum JA, Kann L, Kinchen SA, Williams B, Ross JG, Lowry R, et al.
Youth risk behavior surveillance - United States, 2001. MMWR Surveill
Summ 2002; 51:1-62
9. Anderson RN. Deaths: leading causes for 2000. Natl Vital Stat Rep
2002:50:1-85
10. Gibbons RD, Brown CH, Hur K, Marcus SM, Bhaumik DK, Erkens JA, Herings
RM, Mann JJ. Early Evidence on the effects of regulators' suicidality
warnings on SSRI prescriptions and suicide in children and
adolescents. Am J Psychiatry. 2007 Sep; 164(9):1356-63
11. Wolters Kluwer Health. LEXAPRO projected Unique Patient Counts Since
Launch. August 2007.
SOURCE Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President, Investor Relations, of
Forest Laboratories, Inc., 1-212-224-6714 or Charles.Triano@frx.com
Web site: http://www.frx.com
(FRX)