1000x More Powerful Than Morphine: Snail Venom Approved for Pain Relief

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New Drug Is Approved To Treat Chronic Pain
Synthetic Snail Venom Is Considered a Last Resort

By Marc Kaufman
Washington Post

Wednesday, December 29, 2004

A synthetic form of a sea-snail venom was approved yesterday by the Food and Drug Administration as a novel approach to treating severe, chronic pain.

The drug, called Prialt, was approved for hard-to-treat pain associated with cancer, AIDS and neuropathies. Based on a compound found in the poison of the South Pacific cone snail, it controls pain in a new way -- by blocking the calcium channels in nerve cells that transmit pain signals -- and may have broad implications for the future of pain management.

Because it is as much as 1,000 times more powerful than morphine, it is considered a last resort for long-suffering patients, rather than a first-line pain medication. But the manufacturer, Elan Corp. of Ireland, hopes that will change.

Researchers believe the snail venom, and products like it, can become an alternative to opioid drugs such as OxyContin and morphine. Ultimately, it may also provide an alternative for severely affected patients dependent on medications such as Celebrex, Aleve and now-withdrawn Vioxx -- which have come under fire because of indications that they may cause heart problems.

"This drug is very exciting because it's a very potent analgesic but isn't a narcotic," said Richard L. Rauck of Wake Forest University medical center and the Carolinas Pain Institute. Rauck, an investigator for one of the Elan-funded clinical trials that led to yesterday's FDA approval, said he found the drug to be "effective in almost all types of chronic pain it's been studied in."

What will limit the use of Prialt, and other potential drugs derived from tree frogs and other creatures with natural venoms, is that it cannot be taken in pill form. It has to be delivered directly into the fluid that surrounds the spinal cord, which carries it to the brain without affecting other organs. Because it is so potent, tiny amounts of the drug could be dangerous to the heart and possibly other organs.

"This drug is for patients in chronic and severe pain who are not getting substantial and meaningful relief with oral opiates, or are having unacceptable side effects with them," said Robert Meyer, director of the FDA's Office of Drug Evaluation II. "At this point we don't see this class of drug expanding to general use."

Nonetheless, Elan's president for global research and development, Lars Ekman, said as many as 100,000 people in the United States might be helped by the drug.

He said about 50,000 patients have implanted or external devices that pump morphine directly into the spinal column, and many of them may want to try Prialt because opioids can gradually lose their effectiveness. In addition, he said, many patients in severe pain who take pain pills may want to try the spinal cord route if the drug involved is not an opioid.

"There are thousands of people out there who have pain like a bad toothache all day and night, week after week," Ekman said. "Many of these people have tried morphine and it either didn't work or made them unable to function."

Elan, a relatively small company, has won FDA approval for two novel drugs in two months. In November, the FDA approved its multiple sclerosis drug Tysabri.

Prialt is a synthetic form of the venom that the Conus magus cone snail, which lives in tropical saltwater shallows, uses to stun passing prey.

Efforts to turn the substance into a pill faltered because of its potency, but researchers found that small drips of the drug into the spinal cord fluid went safely to the brain.

In 2000, the FDA required an additional clinical trial to better determine the best dosages, and Ekman said patients will initially receive smaller amounts as a result.

Chris McNeil, a California small-business man who has taken the drug for almost a year as part of a clinical trial, said it has changed his life. He said sharp, unexplained pain in his legs -- and the fog that enveloped him when he took opioid painkillers -- had kept him virtually homebound for six years.

"Once I started taking the new drug, I could walk again and laugh again and start having a life," said McNeil, 48. "I lift heavy boxes in my shop and even play a little soft tennis."

Prialt, which is expected to reach the market next month, will come with a "black box" warning regarding its risks, which include hallucinations and even psychosis in vulnerable people. McNeil said he experienced hallucinations in the first two weeks he was taking the drug, but they stopped.

Despite the limitations of Prialt, Mary Pat Aardrup, executive director of the National Pain Foundation, a nonprofit education group, called yesterday a "red-letter day" for pain patients. "To have another pain drug in an entirely new class is very exciting and very hopeful."

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Good news for pain patients, possibly bad news for opiate abusers...But there's no way that opiates would ever fully be replaced.
 
Awesome news :)

Prialt, which is expected to reach the market next month, will come with a "black box" warning regarding its risks, which include hallucinations and even psychosis in vulnerable people. McNeil said he experienced hallucinations in the first two weeks he was taking the drug, but they stopped.

Probably some form of delirium from messing with calcium levels in the brain?

When it says it needs to be administered to the spinal cord, is that the same method as used when woman are giving birth (epidural)?

For hospital settings that'd be fine, but how much of a hassle would that route of administration be for day to day pain management? Is it a drug which has a long duration, or does one need to redose on a daily basis?

It does sound promising, I would hate to have to manage chronic pain with opiates...

(coz that'd totally destroy your tolerance for getting smacked out! Oh, and that pesky addiction)
 
There just going to start giving this drug out to everyone and tell us 5 years from now "oops, looks like putting snail venom in your spinal fluid isn't such a good idea, try new frog poison!"
 
^There are hundreds and hundreds of millions of people in the united states. This article specifically stated that

"Nonetheless, Elan's president for global research and development, Lars Ekman, said as many as 100,000 people in the United States might be helped by the drug."

That's coming from the R&D head of the manufacturing company, and it's probably an overstatement for that reason. Either way, 100,000 is a small fraction of hundreds of millions.

Also, if this needs to be injected into the spinal column of an individual, and it's "1000x more potent then morphine" (probably a bs number though :p) then they aren't going to be handing it out to people with broken arms. It's a drug aimed at a pretty specific (and small) demographic.

What you said added nothing to the discussion... It's just worthless speculation that doesn't make any sense. Please think before you post.

BTW I think this is great news... I hope it can help some people, and think it will. Opiates really aren't a great solution to severe pain in the long term at all imo.
 
so, could I buy these snails and extract the venom myself?

I have TMJ and it has just recently started flaring up again (the winter season)
 
I REALLY doubt they would just give out a drug that has to be injected into the spinal column, considering if you don't shoot it up just right you could end up paralysing yourself, so you would need a well trained nurse on hand to shoot you up.


and I am also wondering the same thing everythinginside, I think it said the substance was synthetically made like the venom, so they probably just use certain chemicals in the venom, because the full venom would probably lead to paralysis considering thats what most venom does.
 
For hospital settings that'd be fine, but how much of a hassle would that route of administration be for day to day pain management? Is it a drug which has a long duration, or does one need to redose on a daily basis?


He said about 50,000 patients have implanted or external devices that pump morphine directly into the spinal column, and many of them may want to try Prialt because opioids can gradually lose their effectiveness.


Sounds to me like it might just work in place of existing mechanisms that already deliver pain medication. All this would do is change the drug, not the way in which it is administered...?
 
Chris McNeil, a California small-business man who has taken the drug for almost a year as part of a clinical trial, said it has changed his life. He said sharp, unexplained pain in his legs -- and the fog that enveloped him when he took opioid painkillers -- had kept him virtually homebound for six years.

"Once I started taking the new drug, I could walk again and laugh again and start having a life," said McNeil, 48. "I lift heavy boxes in my shop and even play a little soft tennis."

This is what made me curious as to how the medication was delivered. A constant, plugged in "drip" style mechanism, where the patient needs to keep this box with 'em.
Or an Outpatient setup, where they go in to get their dose?

*shrugs*
 
What you said added nothing to the discussion... It's just worthless speculation that doesn't make any sense. Please think before you post.
What has been in the news lately hmmmm....vioxx, aleve, ibuprofen, oxycontin, celebrex, bextra and now snail poison. I don't think it is that farfetched that the fda will screw the pooch and approve yet another toxin without knowing much about its long term effects (botox anyone?). Just because I phrase my responses in a lighthearted manner doesn't mean I don't think. I'm always speculative and cynical when I hear about any new pain treatments these days and shouldn't everyone be? Everyone wants to wrap their arms around the next cure and then everyone gets bit in the ass for it so often to the point that people won't even be able to sue drug companies, HMO's, doctors or hospitals for very much at all in terms of pain and suffering. The vioxx settlements will probably be the last to have large amounts of pain and suffering settlements totalling in the millions for compensation. In a few years the cap will be about $200,000 which I'd say is about equal to the healthy brain or heart vioxx would have been responsible for destroying. Jury award caps are bullshit, it should be everyone's right to sue an HMO and I have gone way off here but fuck new pain drugs, we have a reasonably safe way to treat pain now why not explore further into narcotic treatments then treat the American people like guinea pigs for the drug companies?
 
http://www.bluelight.ru/vb/showthread.php?s=&threadid=175214

and from conversations with my mom who had the option of getting this device during the trials (late stage cancer) the device is actually implanted underneath the skin, and you have to go in to the doc where they refil the medicine as needed. It's not like daily injections or anything like that, just a small device under the skin which has access to the spinal column.
 
Awesome news! I had heard rumors about scientists developing drugs based on cone snail venom for a while, but this is the first time I've heard of it actually being used. Who knows what other medical goodies are out waiting in nature's pharmacy?
 
For people with fucked up backs (broken verbrates & discs) where pain clinics are overwhelmed, opiates fail (not to mention their side affects) and other solutions inflame the situation (steriods causing weight gain) i think a drug that improves the quality of life for these worst case scenarios is something to consider at the very least. Sure the FDA have approved some losers but how much of percentage is that compared to all the relatively successful drugs its reviewed and approved, which have improved the quality of life of millions?

since these people live pretty awful lives i can't see snail venom being anything worse then they've already gone through.
 
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