HOUSTON, LONDON and RESEARCH TRIANGLE PARK, N.C., Nov. 2 /PRNewswire/
-- Fabre-Kramer Pharmaceuticals Inc. (FKP) and GlaxoSmithKline (NYSE: GSK)
announced today that the U.S. Food and Drug Administration (FDA) has issued
a not approvable letter for the new drug application for gepirone extended-
release (ER) tablets, submitted for the treatment of adults with major
depressive disorder.
The FDA had previously reviewed Phase I through III clinical data
involving gepirone ER. In June 2004, the FDA requested an additional
positive short-term trial in order to consider gepirone ER for approval as
a new antidepressant treatment. Subsequently, FKP successfully conducted a
trial in patients with major depressive disorder to respond to the FDA
request for an additional positive pivotal study.
Those results were submitted to the FDA in May 2007. The not approvable
letter issued today is based on the FDA review of those additional results
along with other newly submitted and previously submitted data.
Fabre-Kramer and GlaxoSmithKline entered an agreement in February of
this year for collaboration on the worldwide development and
commercialization of gepirone extended-release tablets. Fabre-Kramer and
GSK are evaluating the response from the FDA to determine appropriate next
steps.
About Fabre-Kramer Pharmaceuticals
Fabre-Kramer Pharmaceuticals, headquartered in Houston, Texas, is
engaged in acquiring, developing and commercializing psychotropic drugs
that have significant market potential. In addition to gepirone ER,
Fabre-Kramer has 10 other compounds in various stages of development for
indications including depression, anxiety, schizophrenia, Parkinson's
disease and insomnia. For more information, visit FKP's website at
http://www.fabrekramer.com
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For more information, visit GlaxoSmithKline on the World Wide Web
at http://www.gsk.com.
SOURCE GlaxoSmithKline
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http://www.fabrekramer.com
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CONTACT:
US Inquiries: GSK US Media Inquiries, Marc
Meachem or Mary Anne Rhyne, +1-919-483 2839; GSK US
Analyst/Investor inquiries: Frank Murdolo, +1-215-751-7002 or Tom
Curry, +1-215-751 5419; Fabre-Kramer Inquiries: Edward Koehler,
+1-713-975-6900; UK Inquiries: GSK UK Media Inquiries, Alice Hunt
and Joss Mathieson, (020) 8047 5502; GSK UK Analyst/Investor
inquiries: David Mawdsley, (020) 8047 5564 or Sally Ferguson,
(020) 8047 5543
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