Pfizer Halts Clinic Trial of Drug
NEW YORK (AP) _ Pfizer Corp. has halted some clinical trials of a painkilling medication after federal regulators voiced concern over a study suggesting the medication increased incidence of tumors in mice.
New York-based Pfizer sent written notices Monday to hospitals and research centers to stop giving the drug pregabalin to patients who suffer chronic pain.
Pfizer said in a statement late Monday that it still expects the drug to win Food and Drug Administration approval this year despite the setback. There is no evidence that the drug causes tumors in humans, Pfizer said.
The FDA cited results of a study that found the drug increased incidence of a particular type of tumor in mice. However, ``a similar lifetime dosing study in rats did not show increases in any tumor type,″ Pfizer said.
Pfizer spokeswoman Mariann Caprino said Tuesday that while the pain-related clinical trials have been halted, others are continuing for patients with epilepsy and a variety of anxiety disorders. About 2,400 people nationwide are involved in the trials, including 1,000 in the pain trials.
``Patients in those (pain) trials who have not responded to other therapies will have the option of continuing on the drugs,″ Caprino added.
The drug was hailed as a leap for painkilling with the power of morphine _ but without morphine’s side effects. It has been given to people with pinched nerves, shingles, HIV, stroke or other chronic and painful illnesses.
Pfizer hoped pregabalin could help as many as 39 million Americans who suffer chronic pain, and could generate as much $700 million in annual sales for the nation’s largest pharmaceutical company.
Shares of Pfizer were down $1.09, or 2.4 percent, to close at $45.03 Tuesday on the New York Stock Exchange.
On the Net: http://www.pfizer.com