NEW YORK, May 6 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) today announced the results of a clinical study, which found that
Lexapro(TM) (escitalopram oxalate) is a beneficial and well-tolerated
treatment for depressed patients who failed to respond to initial
antidepressant therapy with any one of four other selective serotonin reuptake
inhibitors (SSRIs). In addition, 60 percent of patients who were switched to
Lexapro responded and more than 40 percent achieved remission of depressive
symptoms after failing initial antidepressant therapy. The findings were
presented at the 157th annual meeting of the American Psychiatric Association
in New York.
"Forty percent of patients achieving remission from Lexapro after not
responding to another SSRI is remarkable," said Dan L. Zimbroff, M.D., lead
study investigator and medical director of the Pacific Clinical Research
Medical Group in San Bernardino, California. "These results bring hope for
both doctors and patients who have experienced difficulty in finding an
effective treatment option."
Depression affects nearly 19 million adult Americans and costs the United
States an estimated $44 billion each year. Symptoms of depression often
include frequent feelings of worthlessness or guilt, difficulty concentrating,
loss of interest in activities, and a change in eating or sleeping habits.
The World Health Organization predicts depression will become the leading
cause of disability by the year 2020.
Study Conclusions
At the end of the eight-week treatment period, Lexapro was shown to be
beneficial and well tolerated in patients who did not respond to initial SSRI
therapy, including Zoloft(R) (sertraline hydrochloride), Prozac(R) (fluoxetine
hydrochloride), Celexa(TM) (citalopram HBr), and Paxil(R)(paroxetine
hydrochloride). Approximately 60 percent of previously, non-responding
patients met the criteria for response and more than 40 percent achieved
remission of depressive symptoms when treated with Lexapro. Regardless of
which SSRI treatment patients were started on, Lexapro was beneficial in
achieving response and remission. Remission was defined as a MADRS score of
less than or equal to 10 and represents a resolution of depressive symptoms
and restoration of normal functioning.
In the study, non-responders to initial SSRI therapy were safely switched
to Lexapro within 24 hours. Lexapro was well tolerated, with only 6.6 percent
of patients withdrawing from the study due to adverse events associated with
Lexapro treatment, following therapy with another SSRI. Headache was the only
adverse event reported by more than 10 percent of the patients treated with
Lexapro following treatment with another SSRI.
Study Methodology
Five hundred and fifteen patients, ages 18 to 65 with major depressive
disorder (baseline MADRS score greater than or equal to 22), participated in
an eight-week, lead-in treatment period with an initial SSRI. Patients were
randomized to receive open-label, flexible dose treatment of citalopram (20-60
mg per day; N=131), sertraline (50-200 mg per day; N=127), paroxetine (20-50
mg per day; N=128), or fluoxetine (20-80 mg per day; N=129). At the end of
the lead-in period, 137 patients who completed the trial and did not respond
to initial treatment (MADRS >12) participated in an eight-week, open-label
trial of Lexapro at 10-20 mg per day. Patients were switched to Lexapro
within 24 hours of discontinuing initial treatment. Response at the end of
the lead-in treatment period was defined as a MADRS score less than or equal
to 12. At the end of the Lexapro treatment period, response was defined as at
least a 50 percent reduction in MADRS scores from the beginning of the lead-in
treatment period. Remission was defined as a MADRS score of less than or
equal to 10.
About Lexapro
Lexapro is the newest and fastest-growing selective serotonin reuptake
inhibitor (SSRI) and has been prescribed for more than 4.5 million patients in
the U.S.
Lexapro was approved by the U.S. Food and Drug Administration (FDA) in
August 2002 for both the initial and maintenance treatment of major depressive
disorder and in December 2003 for the treatment of generalized anxiety
disorder. Lexapro is available as tablets and oral solution.
As with all SSRIs, Lexapro should not be taken with monoamine oxidase
inhibitors (MAOI). 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.
Patients with major depressive disorder, both adult and pediatric, may
experience worsening of their depression and/or the emergence of suicidal
ideation and behavior (suicidality), whether or not they are taking
antidepressant medications, and this risk may persist until significant
remission occurs. Although no causal role for antidepressants in inducing
such behaviors has been established, patients being treated with
antidepressants should be observed closely for clinical worsening and
suicidality, especially at the beginning of a course of drug therapy, or at
the time of dose changes, either increases or decreases.
Forest Laboratories licenses Lexapro from H. Lundbeck A/S, the Danish
pharmaceutical firm that developed escitalopram and citalopram.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro(TM), an
SSRI antidepressant indicated for the initial and maintenance treatment of
major depressive disorder and for generalized anxiety disorder; Celexa(TM), an
antidepressant; Namenda(TM), an N-methyl-D-aspartate (NMDA)-receptor
antagonist indicated for the treatment of moderate to severe Alzheimer's
disease; Tiazac(R), a once-daily diltiazem, indicated for the treatment of
angina and hypertension; Benicar(R),* an angiotensin receptor blocker
indicated for the treatment of hypertension; Benicar HCT (TM), an angiotensin
receptor blocker and diuretic combination product indicated for the second-
line treatment of hypertension; and Aerobid(R), an inhaled steroid indicated
for the treatment of asthma.
* Benicar(R) is a registered trademark of Sankyo Pharma, Inc.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements are subject to risks and
uncertainties that affect our business, including 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, 2003 and Quarterly
Report on Form 10-Q for the period ended June 30, 2003, September 30, 2003,
and December 31, 2003. Actual results may differ materially from those
projected.