WASHINGTON, Dec. 28 (AP) - The government approved on Tuesday a drug that offers a new way of fighting severe pain, an option for patients who no longer benefit from morphine and other traditional pain medications.
The drug, made by the Elan Corporation, is the first in a new class of drugs that selectively blocks the nerve channels responsible for transmitting pain signals. It will be marketed as Prialt and should be available by the end of January.
'When you've taken all the kinds of pain medication that there is and you still have pain, that is a very frightening situation,' said Dr. Lars Ekman, president of research and development for Elan, which is based in Dublin. 'When you have that kind of pain, there is nowhere to go.'
The drug is part of a new class known as N-type calcium channel blockers. It is known chemically as ziconotide.
The Food and Drug Administration approved the drug for patients who no longer receive relief from morphine and have moved to the next level of treatment, which involves a pump that delivers medicine directly to the area around the spine.
Prialt has been studied in patients with cancer, AIDS and other afflictions that produce chronic pain. More than 1,200 patients took part in three clinical trials.
There are side effects, and the F.D.A. said it would require its strongest warning to appear with the drug. Side effects may include dizziness, drowsiness and altered mental status, with patients confused at times.
Despite the side effects, the drug was approved because there are no other options for these patients and the benefits outweighed the risks, the agency said.
31 December 2004
From the NYT:
Posted by Adam at 9:55 AM