Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
November 29 2007 - 9:00AM
PR Newswire (US)
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
(http://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.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President, Investor Relations, of
Forest Laboratories, Inc., +1-212-224-6714 or Web site:
http://www.frx.com/
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