FDA Approves New Drug for SeverePain
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Sent: Wednesday, December 29, 2004 1:12 PM
Subject: Yahoo! News - FDA Approves New Drug for SeverePainFDA Approves New Drug for Severe Pain.
The Food and Drug Administration on Tuesday approved the first in a new class of drugs that blocks the nerve channels responsible for transmitting pain signals. It will be marketed as Prialt and should be available by the end of January.
The drug is part of a new class known as N-type calcium channel blockers. It is known chemically as ziconotide.
Morphine is standard treatment for severe pain... This is the first new drug in 20 years to treat pain using such a pump.
Prialt has been studied in patients with cancer, AIDS and other chronic pain, such as back pain. More than 1,200 patients took part in three clinical trials.
There are side effects, and the FDA was including a "black box" warning the government's strongest warning short of a ban. 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, said Dr. Robert Meyer, director of the FDA's Office of Drug Evaluation II.
Patients with a history of psychoses should not receive it, and all others should be monitored for signs of cognitive impairment, he said.
The idea for the drug came from a snail called the Conus magus that lives in the South Pacific, which paralyzes its victims with venom after capturing them, the company said.