Posted on 12/28/2004 2:47:28 PM PST by neverdem
Filed at 4:45 p.m. ET
WASHINGTON (AP) -- The government approved a drug Tuesday that offers a new way of fighting severe pain -- an option for patients who no longer benefit from morphine and other traditional pain medications.
It's 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 the drug's Ireland-based manufacturer, Elan. ``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.
Morphine is the standard treatment for severe pain from cancer, AIDS, amputations and other significant illnesses, but its effects eventually wear off and the dosage must be increased. At some point, many patients switch from taking medication by mouth or by injection to a microinfusion pump implanted under the skin that delivers drugs directly into the fluid surrounding the spinal cord.
Ekman said about 35,000 to 50,000 Americans have these pumps now. The Food and Drug Administration approved Prialt for patients who are already using these pumps but not getting effective relief from them or who cannot tolerate the available treatments.
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.
``Because this is such an important patient population where they have such pain and they have so few options we felt this drug does offer some real gains,'' he said.
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. Researchers set out learning how to develop a drug based on this venom and eventually copied the amino acid sequence.
Elan would not say how much it plans to charge for the drug.
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On the Net:
FDA: http://www.fda.gov
Elan: http://www.elan.com
Cool!
pot?
How long till the FDA takes them off the market due to side effects?
Where do we sign up to sue?
Is it supposed to work for liberals' post-election pain?
I doubt that. Morphine can kill. It's not being halted. This is for folks with infusion pumps when morphine doesn't cut the mustard anymore.
FReepmail me if you want on or off my health and science ping list.
If the FDA were a private company, the feds would shut them down and the trial lawyers would be feasting on the carcass.
Elan's on a roll it seems.
They just developed a MS drug that is supposedly twice as effective as the interferons, and is given by infusion.
Yearly cost for that drug is estimated to be $25,000 per year. Wonder what the charge for this med will be?
Don't underestimate the stupidity of the FDA or Congress.
This new drug sounds interesting. I'll be getting some surgery in February and it will be painful. I'll test it out.
Now that the FDA has approved it, The DEA will regulate it. The people that 'really' need it will die in pain. How do these Dr.'s sleep at night.
/Chronic pain sufferer gets off the soapbox (now)
Wow ! A Black Box Warning.........Where can I get a 5 gallon can of this stuff and a straw !
Whoa ! What did ya break BD ?........yer back ??
Bottom line is to stay away from jumping horses and don't tailgate large trucks on the interstate. The ankles were from landing a plane in a field and not getting it stopped in time for a creek embankment while still moving at a good clip. Keep your feet off the rudders and floorboards once crashed.
The surgery this season is to keep me from getting frozen shoulders. Every few years I need clavicular resections due to calcification from prior damage.
You betchya! I'll let you know. Knees are tough because you're dealing with two different types of pain, both skeletal and soft connective tissue. The big-time stuff is great on skeletal but iffy on connective tissues which are on fire. Pain sure keeps you alert though huh? Nature's pretty cool when you think about it. I find shock to be like an acid trip. It's like being outside your body and looking back in. Time stands still. Your mind drifts elsewhere and yet you see and hear everything around you.
Sorry to hear all that fun has come back on ya so hard. Hope ya at least had the doors open on that AC crash.....:o)
All my back injuries came from thin air PLF's and too many sudden stops. Never crashed a fixed wing, a few dead stick landings etc but broke a bunch of tail booms and skids in auto rotations on old UH-1's and got shorter every time......now the back is broke and hurts but I'll not whine in your presence. I fit as a fiddle compared to your status. Surgery is on the horizon for me too...again.
Hope they get ya back to no pain status at the very least.....Stay safe !
I've even developed a resistance to anesthesia drugs. It used to be I was out in a second. Now I feel it burning and get that metalic taste in my mouth. They have to hold me down. The burning pain in the veins is just brutal. Last time they were super generous with the valium shots in pre-op. It didn't help at all. It just made the music more enjoyable. Being operated on to BB King is quite an honor. It takes about fifteen seconds for me to drop out cold now. Amazing the ways the body adapts.
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