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FDA Advisory Committee Recommends
Approval for Namenda (Memantine HCl) For Moderate to Severe
Alzheimer's Disease
NEW YORK, NY -- September 25, 2003 --
Forest Laboratories (NYSE: FRX) announced that an advisory committee
to the U.S. Food and Drug Administration (FDA) unanimously recommended
the approval of Namenda(TM), previously known by its generic name
memantine HCl, for the treatment of moderate to severe Alzheimer's
disease. The FDA will consider the recommendation of the Peripheral
and Central Nervous System Drugs Advisory Committee as it completes
review of the New Drug Application for Namenda.
"Forest is pleased with today's
unanimous vote to recommend the approval of memantine," said Lawrence
Olanoff, M.D., Ph.D., Executive Vice President of Scientific Affairs
at Forest Laboratories. "Memantine has shown a significant and
consistent benefit for moderate to severe Alzheimer's patients in
multiple, well-controlled trials when used alone or in combination
with a currently approved treatment. It is the first in a new class of
Alzheimer's medications with a mechanism of action that differs from
currently available therapies. We will work with the FDA to attempt to
achieve the approval of memantine as soon as possible. We expect
memantine to be available within a few months of FDA approval."
Meeting in Bethesda, Maryland, the
Advisory Committee comprised of experts in dementia and other
neurological disorders, reviewed data from two U.S. placebo-controlled
Phase III clinical trials and an earlier trial conducted among nursing
home patients in Europe. Phase III data included a 28-week monotherapy
study of 252 patients published earlier this year in the New England
Journal of Medicine and a six-month, 401-patient study of Namenda used
in combination with an ongoing regimen of the commonly used
Alzheimer's agent donepezil. In clinical trials, Namenda has been safe
and well tolerated. The most common adverse advents observed in
clinical trials are dizziness, headache, fatigue and somnolence.
"The number of people suffering from
moderate to severe disease is significant today, and the prevalence of
the disease will continue to grow exponentially," said Steven DeKosky,
MD, Chairman of Neurology at the University of Pittsburgh and
presenter at today's hearing. "Currently, this is a population that is
at risk of being left behind. Memantine, if approved, should be an
important addition to the treatments a physician can offer patients."
About Namenda and
Alzheimer's Disease
Namenda (memantine HCl) is the first of a new class of medications for
Alzheimer's disease with a mechanism of action distinct from currently
available drugs. Namenda is a low to moderate affinity NMDA
(N-methyl-D-aspartate) receptor antagonist. It is thought that
overexcitation of NMDA receptors by the neurotransmitter glutamate may
play a role in Alzheimer's disease since glutamate plays an integral
role in the neural pathways associated with learning and memory. The
excitotoxicity produced by abnormal levels of glutamate is thought to
be responsible for neuronal cell dysfunction and the eventual cell
death observed in Alzheimer's disease. Namenda is thought to
selectively block the excitotoxic effects associated with abnormal
transmission of glutamate, while allowing for the physiological
transmission associated with normal cell functioning.
Alzheimer's is a progressive disease
of the brain that is the most common type of dementia. The term
dementia is used to describe the progressive loss of cognitive,
intellectual or functional abilities. The Alzheimer's Association
projects that by 2010 more than 5.5 million people in the United
States will have Alzheimer's disease. Currently, all Alzheimer's
medications approved in the United States belong to a class of agents
called acetylcholinesterase inhibitors, which are indicated for
patients with mild to moderate symptoms of the disease. Currently,
there are no approved therapies in the United States for people who
have progressed beyond the mild to moderate stages of the disease.
Benicar(R) is a registered trademark
of Sankyo Pharma, Inc.
SOURCE: Forest Laboratories, Inc.
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