Dow Jones: FDA Declares Pfizer Schizophrenia Drug Zeldox Non-Approvable'
June 19, 1998 3:59 PM
NEW YORK -(Dow Jones)- In a surprise blow for
Pfizer Inc., the Food and Drug Administration declared
the pharmaceutical giant's schizophrenia drug Zeldox
"non-approvable."
Pfizer (PFE), which has been on a roll since April with
the launch of its blockbuster impotence drug Viagra,
said Friday it plans to meet with FDA officials to discuss
the issues raised by the agency, and will submit
additional data if necessary.
Along with the now-ubiquitous Viagra, Zeldox was one
of several new drugs Pfizer expected to launch this year.
It was to join the antidepressant Zoloft in Pfizer's
portfolio of mental-health drugs.
Zeldox (known generically as ziprasidone) was expected
to compete aggressively against Eli Lilly & Co.'s
Zyprexa and Risperdal from Johnson & Johnson.
Zyprexa is expected to become the first the world's first
$1 billion-a-year schizophrenia drug. Another
schizophrenia drug, Seroquel, sold by Zeneca Group
PLC, won FDA approval late last year.
Zyprexa and Risperdal have been a boon to
schizophrenia patients because they don't carry some of
the disabling side effects of older drugs.
Schizophrenia, a chronic disorder that involves
hallucinations and a profound withdrawal from society,
has long been one of the world's most devastating
diseases, leading millions to be institutionalized or to lead
desperate lives on the streets.
Schizophrenia and psychosis are probably best known
for causing hallucinations and voices that "speak" to
patients. These are called the "positive" symptoms of
schizophrenia. The disease also has so-called negative
symptoms like lethargy, inability to socialize and lack of
spontaneity.
Many patients can't tolerate the side effects of older
drugs like haloperidol (Haldol) and chlorpromazine
(Thorazine). These drugs cause "extrapyramidal
symptoms," which are jerky, uncontrollable movements
of the arms and legs similar to Parkinson's disease
symptoms.
"We are obviously disappointed at this development, but
remain confident of the safety and efficacy of Zeldox,"
John F. Niblack, Ph.D., executive vice president and
head of research and development at Pfizer, said in a
statement. "We remain committed to making every effort
to bring this medicine to patients in the U.S. and around
the world," he said.
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