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
The thought off goin down in an eggbeater terrifies me. I'm sure you know the mindset of us fixed wing guys...........
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.
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.
Ziconotide: neuronal calcium channel blocker for treating severe chronic pain.
I don't know if they can ever use this class of drugs with an oral route of administration. It's a peptide, i.e. a fragment of protein, that's 25 amino acid residues long. It would start being digested once it's in your gut, IIRC.
Solution structure and backbone dynamics of an -conotoxin precursor
"Side effects may include dizziness, drowsiness and altered mental status, with patients confused at times."
I've been on Morphine and I was drowsy, confused, and kept trying to grab the nurses butt. So what's different? This sounds great.
"I also cannot be numbed".
I got eleven shots of Novocaine at the dentists office with little effect. They finally used gas and demerol.
See my post #25...
Oddly enough however, I was once prescribed Halidol or halcion....I'm not sure which. Knowing my resistance to drugs, I popped three. Legend has it that after a bottle of wine, I greeted a pizza delivery guy at the front door naked, and accused him of hiding my tacos in his vehicle. I remember none of that. Needless to say, I never ordered pizza in that town again!
Does shock make your hands and legs shake too? Just asking because I had an injury once where I was bleeding a lot. My hands and legs were shaking. I never understood why.
Constant shaking and cold. The blood leaves your extremeties and goes to your torso and brain to conserve supplies. Your body knows something is threatening and needs to shut you down before you bleed to death. That's how shock works. Pain seems to be distant as well. In nature you'd crawl under a log or hide in a gulley somewhere in a natural response. Oddly enough you get sort of giggly too.
Oh yea, your so right. I was shaking, and obviously hurt, but still very calm and laughing, kidding around with the paramedics and the cops. It was so weird.
I tried to get an ambulance to stop for ice cream once, while a hunk of leafspring to a truck was impaled thru my chest, lung, and out my back. I was doodling on it with a marker I had in my pocket. I thought ice cream all around was a good idea at the time. Go figure? I think medical crews are used to it.
bttt
"The big-time stuff is great on skeletal but iffy on connective tissues which are on fire."
How can you tell? I have thumb arthritis, tried several things, neurontin also, and including an experimental drug I'm on now. Nothing really seems to work much. My thumbs are fine most of the time but when I use them a certain way, I get zapped with a very sharp pain. It feels like nerve pain to me. I also wonder if it's only thumb arthritis & not something else as well.
You need to make a decision about where you want to go with this. An option is to get cortizone shots in the joint and surrounding tissues to decrease inflamation and theoretically the pain. I've never found it to work. It seems so for a few hours because they dose the cortizone shot up with benzocaine or such to numb the area. It gets you out of the doctor's office. The next is a brace or immobilizer which will prevent pain, but will give you a frozen joint in a year. The next is to undergo surgery where they chisel away bone and smooth it out so the tendons and nerves don't get irritated, pinched or impinged upon during normal movement. It hurts like hell but a month later you'll feel new again. It lasts about five years before it needs to be done again.
Chances are you injured the joint when younger or abused it in your vocation, such as a carpenter swinging a hammer or a mechanic turning a wrench. Since it's your thumb, were you a government worker? (just a joke)
As for the medication issue, it's just a thumb man.......Sure it moved you ahead of other animals and it's brought you this far, but it's not like it's your spine or something more debilitating thank god. Try oral steroids and some tylenol #3's to sleep.
Americans worship the idea that there is a pill for everything. There isn't. If you need extreme pain medication, you need to be in the hospital and on an IV. It's the only way to real pain relief. You won't find heroin addicts liking the idea of taking a pill instead. Pills don't do much. That goes for antibiotics too. Keflex in a pill is worthless on streptococcus. Keflex(cefalexin) in an IV drip is a sure cure for the same condition. Antibiotic pills should be banned. When someone gets a venerial disease, they get a big-o'l shot of intramuscular penecillin variation in the tushy. That's the way any prescription for antibiotics should be dispensed. Oral efficacy of even the most potent antibiotics is dicey at best.
This from who has probably never suffered from longterm intense physical pain. If you had, you would realize how sadistic your comment was.
If you're over 60, no surgery, just oral meds and sympathy. If you're 50 to 59, they calculate the cost of ten years of worthless anti-inflamatories and make you shell out copays for a doctor's visit and new prescription every 30 days, hoping you'll give up. At $40 bucks a month, they're betting you'll take the $40 and spend it on lobster instead. The 10 years of meds are still cheaper than surgery. Remember, it's not results, it's cost driven. Now if you're under 50, your odds are good for getting some help. The costs of meds for three decades meets up with the curve on the graph that some clerk uses at your HMO.
Pharmaceutical companies price target their medications based on what they know insurance carriers will pay vs. surgical alternatives. Your entire medical destiny depends mostly on what an Excel spreadsheet entry churns out after some high speed guzinta's. If it's an HMO and not worker's comp, you're spreadsheet is a done deal and posted inside your bathroom medicine cabinet in the form of a hundred old worthless bottles of pills.
Americans worship pills like the higher god. It's insane. Good marketing though......
Sheesh!
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