NEW YORK, Aug. 26 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that it has submitted a complete response to
deficiencies raised by the FDA Division of Neuropharmacological Drug Products
in its review of the Panic Disorder supplemental NDA submitted for Lexapro in
April, 2003. Lexapro is approved for use in Major Depressive Disorder and
Generalized Anxiety Disorder. An additional Supplemental NDA is under FDA
review for Social Anxiety Disorder.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The FDA notified Forest Laboratories on February 25, 2004 that the
supplemental NDA for Panic Disorder was not approvable based on deficiencies
with regard to the demonstration of efficacy. No safety issues were raised.
The efficacy issues related to FDA concerns regarding the trial methods and
statistical analyses performed for the two placebo-controlled trials provided
in the submission. Both trials involved patients with panic disorder, the
first was a European study which compared different doses of citalopram to
placebo for 8 weeks of treatment followed by a one year extension phase; the
second was a U.S. study which compared either escitalopram or citalopram to
placebo for 10 weeks of treatment. These studies have previously been
published.
Forest Laboratories believes it has fully addressed each of the FDA
comments in its response and is hopeful that after additional FDA review, the
panic disorder indication will be granted approval. The company believes that
the panic disorder indication will not materially affect Lexapro sales.
Publications:
J Clinical Pyschiatry: 1998;59;528-534
J Psychiaty and Neuroscience: 2000;25;25-32
J Clinical Psychiatry: 2003;64;1322-1327
Br. J Psychiatry: 1997;170;549-553
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, 2004 and on form
10-Q for the period ended June 30, 2004. Actual results may differ materially
from those projected.
SOURCE Forest Laboratories, Inc.
-0- 08/26/2004
/CONTACT: Charles E. Triano, Vice President - Investor Relations,
+1-212-224-6714, or Charles.Triano@frx.com, for Forest Laboratories, Inc. /
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com/
/Web site: http://www.frx.com /
(FRX)