Posted by bonnie_ann on February 3, 2002, at 12:43:35
Lexapro(TM), The Single-Isomer of Celexa(TM), Receives FDA Approvable Letter
FOREST LABORATORIES LOGO
Forest Labratories Inc. Logo. (PRNewsFoto)[AG]
NEW YORK, NY USA 10/11/2000
NEW YORK, Jan. 24 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that it has received an approvable letter from the
United States Food and Drug Administration (FDA) for Lexapro(TM) (escitalopram
oxalate). Lexapro, the single-isomer of Celexa(TM) (citalopram HBr), is being
developed by Forest Laboratories for the treatment of major depressive
disorder. An approvable letter represents the final stage before a company
receives FDA clearance to market the product in the United States. Forest
expects to launch Lexapro in mid-2002 subject to final FDA approval.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Forest filed a New Drug Application (NDA) for Lexapro, a selective
serotonin reuptake inhibitor (SSRI), in March 2001. The NDA was based on a
fixed dose trial of Lexapro compared to placebo and Celexa. Forest and
Lundbeck (Forest's licensor of Lexapro) have conducted several multi-center,
placebo-controlled clinical trials involving more than 1,300 patients with
moderate to severe depression. In the trials, Lexapro was shown to be well
tolerated and to significantly improve symptoms of depression in the first or
second week of treatment. The most frequent adverse events observed in these
trials were nausea, insomnia and ejaculation disorder. In fixed dose studies,
the overall incidence rates of adverse events in patients treated with Lexapro
10 mg daily was similar to that in placebo treated patients.
"We are very pleased to receive an approvable notification from the FDA,"
said Howard Solomon, Chairman and Chief Executive Officer of Forest
Laboratories. "The approvable letter does not raise any clinical issues with
respect to Lexapro and we expect to be able to adequately respond to the
letter and agree to final labeling."
Lexapro 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 made up of equal amounts of two mirror-image
molecules called the S- and R-isomers. The S-isomer of Celexa (Lexapro) is
the active isomer in terms of its contribution to Celexa's antidepressant
effects. With Lexapro, 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 Lexapro (the S-isomer) eliminates any
potential unwanted effects associated with Celexa's R-isomer.
In the United States, approximately 19 million adults suffer from
depression each year. It is estimated that one in four American women and one
in ten American men can expect to develop depression during their lifetime.Studies in Other Indications
Forest Laboratories also stated that it was pleased with the results of
initial placebo controlled Lexapro clinical trials in Generalized Anxiety
Disorder, Panic Disorder and Social Anxiety Disorder. Results of those
studies are expected to be reported in March at the Anxiety Disorders
Association of America annual meeting.About Forest Laboratories and Its Products
Forest Laboratories 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: Celexa(TM), which
has been prescribed for more than six million U.S. patients and is the fastest
growing antidepressant in the U.S.; Tiazac(R), a once-daily diltiazem, which
is indicated for the treatment of angina and hypertension; and Aerobid(R), an
inhaled steroid indicated for the treatment of asthma.
Other 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, Aerospan(R) for asthma, and ALX-0646 for
migraine headache.My understanding is that the adverse effects experienced by the Lexapro group were similiar to the placebo group. The other side effects listed were refering to the Celexa group!?
Bonnie
poster:bonnie_ann
thread:92705
URL: http://www.dr-bob.org/babble/20020131/msgs/92705.html