halts third study of experimental pain drug
— Drugmaker Pfizer Inc. has stopped patient tests of an experimental
drug for two types of pain at the request of federal regulators, just weeks
after halting its testing in arthritis patients.
Pfizer was testing
tanezumab in patients with chronic low back pain and with painful nerve
damage from diabetes complications. Both were late-stage studies. For now,
the two studies won't add new patients and will have study participants
stop taking their pills.
They were part
of a program of nearly 20 patient studies of the drug, including several
for osteoarthritis, a very common condition caused by wear and tear on the
joints. That's a potentially huge market as baby boomers age.
comes less than four weeks after safety problems led Pfizer to halt testing
of tanezumab in patients with osteoarthritis because it worsened in some
patients, requiring joint replacements. That decision also was due to pressure
from the U.S. Food and Drug Administration.
Pfizer said the FDA made the new request after further review of reports
of harm to patients with osteoarthritis. Pfizer said it will keep working
with the FDA to decide how to handle all future human testing of the drug.
The study failures
are part of a worrisome trend at Pfizer, which is the world's biggest drugmaker
by revenue and spends about $9 billion a year trying to develop new drugs.
In the last 18
months, about a dozen studies of experimental drugs Pfizer was testing for
Alzheimer's disease, or various types of cancer and pain, failed because
of poor efficacy or safety problems not seen in years of prior research.
The Alzheimer's drug was highly anticipated, and doctors called the failure
a big setback because many hoped it might be the first treatment to stop
or reverse the mind-robbing disease.
faces generic competition at the end of next year for its blockbuster cholesterol
fighter Lipitor, which brings in about $13 billion a year, nearly one-quarter
of company revenue.
Mackay Jimeson said one late-stage study of tanezumab for treating osteoarthritis
patients has been completed. Two other late-stage osteoarthritis studies
have finished treating patients and their data is being analyzed.
studies have stopped recruiting new patients and giving study participants
Jimeson said three
other nonarthritis studies — two for cancer pain and one for chronic
pancreatitis — will continue, but they will exclude any arthritis
rose 17 cents to $14.73 in regular trading Monday, then fell 8 cents in
2010 The Associated Press. All rights reserved.
By Linda Johnson