Suzetrigine - a novel drug for pain

Posted by kdks99 @kdks99, Jan 26 11:32am

ok...So here's what I know and what I think is true. This drug was FDA fast tracked. The results of the phase 3 clinical trial for acute pain were very good. It was on track to be approved on 1/30/25 but due to an executive order regarding FDA communications it is not clear if the FDA will be allowed to release the approval or not.
https://www.goodrx.com/conditions/pain/opioid-alternatives
Vertex completed a phase 2 study and the results were inconclusive due to poor study design. After reviewing the results it is my opinion if a better designed phase 3 is approved the results will be similar to the study for acute pain. This is the first new non-opioid pain medicine in 20 years.

Once it is approved I plan on insisting my doctor writes an off label script so I can try it even though my pain, like your's is chronic. The side effect profile is excellent..i.e. there were actually MORE side effects in the placebo arm of the study... doesn't get better than that.

That being said, there is no information on the side effects for chronic pain, which would require long term use but after reviewing the research i will take a chance.

I am not sure about how the medicare coverage will work, but once it is approved I will look into it and share with you here. I think they may have to pay for it if your doctor writes a script off label or not.
https://www.nopainpact.com/pdf/Nopain_Act_Guide_Implementing.pdf
This has the potential for being a game changer so I think we need to educate our doctors and do
our own research.

Please let me know if I can provide links to more information that might help you.

Like Helpful Hug

Interested in more discussions like this? Go to the Chronic Pain Support Group.

@cheryl333

That sounds so promising. I've been praying for a non-opiate pain med for us chronic pain sufferers. Percocet works great for me but doctors won't prescribe it anymore. They act like I'm a drug addict just for asking. I would love some more info on it and I have an appointment with my Pain Management doctor in a couple of weeks and I'll ask her if she's heard if it. Thank you so much for sharing!

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Take it up with your MD again. The very fact you're asking for this should indicate to even the slowest-witted MD that you're not an addict: Journavx (Suzetrigine) is NOT an opioid. Won't do a thing for an opiate addict. If your MD thinks you're weaseling opiates by asking for this stuff, he's an idiot.

REPLY
@bayhorse

Confused about what this drug actually can treat. The good Rx article mentions neuropathy, particularly diabetic neuropathy, and makes a comment about peripheral nerves. But will it be used to treat nerves in the spine? I have severe lumbar stenosis and pain in glutes, hamstrings, calves, ankles. Are the researchers looking for applications for spinal stenosis?

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Journavx is being marketed for acute (short-term) significant pain. Classic instance would be surgery for broken bones, etc. The phase 2 trial was apparently equivocal, & even it only sought short-term benefit for acute pain. NOT chronic pain.
Severe stenosis? Sorry: they won't be applying for that kind of application until at least after a Phase 3 trial for acute pain.
That doesn't mean your MD can't apply to use it off-label for chronic pain, especially under the Compassionate Care Act if you qualify. But again, that won't likely be a possibility until after a Phase 3 trial reports. That's a few years away, best case.

I do expect there'll be a rush of requests for off-label use, & suspect the pharma company is counting on that. Doctors are under tremendous pressure to reduce their prescription of opioids; patient demand for non-opioid pain meds that work is enormous. I'm sure the pharma company realizes it's sitting on a golden goose & they'd better not F it up by rushing to market, appearing to too obviously game the approvals process, or look too greedy.
If this stuff is relatively side-effect free, not too expensive and actually IS as effective as opiates, there's not only a Nobel prize in store for them, it'll be the blockbuster of the century.

I'm not them - especially not their lawyers - but I'd argue for speedy approval to provide under the Compassionate Care Act free or at very affordable price, on condition that all such use be tracked & outcomes reported meticulously. Such a process would tell the FDA more than even a large Phase 3 trial while demonstrating compassion & concern for patients. And should demonstrate just how amazing such a drug is. They could even supply it free: this kind of program would create more and better data than a Phase 3 trial at a tiny fraction of the cost. No way would such a program cost $20-30 million, and that's the cost of an ineffectually-small phase 2 trial today. A bargain! All while generating market awareness & demand - advertising-free - and generating enormous goodwill. A bargain!

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@bajjerfan

"Off label" generally refers to use of a drug to treat a condition for which it has not been approved by the FDA. IIRC years ago the was a BP med called Clonidine that was said to be useful in helping folks stop smoking. A physician could prescribe it for that use even tho it wasn't approved for that use.
I had growths on both adrenal glands that were producing cortisol. Last August I had one adrenal gland and its growth removed and I'm still producing too much cortisol. I'm currently involed in a reserach trial at Mayo with a drug that may help regulate cortisol levels. It is currently used to help diagnose adrenal insuffiency or not producing enough cortisol. I'm not too keen on giving up my other adrenal gland and living on meds the rest of my days.

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We wish you well with that. Yeah, you definitely want to hang onto that organ if you can.
I too have run into surgeons pitching the line: "No problem; you can live without that." Easy for them to say: they're on the right end of the scalpel, and THEY don't have to live with the outcome. Not that they care: surgeons think with the tools they got, which means a scalpel. If they can't cut it, it doesn't exist & doesn't matter: they don't care about it. That's someone else's problem.
I lost my spleen in a bicycle accident in my youth. I understand you can live without certain organs - that one included - but there are DEFINITELY outcomes. Problems. You wouldn't choose to lose ANY organ if at all possible. There is, after all, a reason why they're there.
Regulating your immune & hormonal systems - which regulate everything else - without your adrenal - or thyroid - glands, is problematic at best. Not what you want.

Don't know about adrenals, but if the problem is a growth it prompts me to consider nodules in the thyroid. Just as you've found, surgeons are quick to whip it out, leaving you attempting to balance your systems on drugs for life. Even investigative procedures can frequently (50%) result in loss of the organ. I had a large-bore needle biopsy done. Why can't they treat it the same way we do plantars warts? Inject a little liquid nitrogen, freeze/kill the nodule cells & flag the thing for clean-up by your immune system. "No way anyone would do that!" was the response. So I hit Google: turns out they DO do that, first in Turkey, then Israel, now it's spread to Germany. We'll do it in the US then Canada in another 5-10 years, because... "weird", "we didn't think of it", "it's different", and (my favorite) because "it doesn't use my scalpel." < sigh>

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@flyjim

Just asked my PCP about it two weeks ago. Never heard of it.
Asked my orthopedic surgeon and he said he wrote one script to someone that had a previous prescription from her previous home town. Ask my spinal pain interventionist and he said he won’t waste his time as of now because it’s to expensive, the company wants a letter from the Dr. as to why he is prescribing it as they might help out with the cost but his research indicates they usually decline it.
Also, not approved for chronic pain, only acute as in post op pain. Long story short,
America, best healthcare in the world if you’re wealthy.

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"Just asked my PCP about it two weeks ago. Never heard of it." - Yup. Classic.
Here's the rule of thumb: "Doctors all stop reading the minute they graduate." That's Thompson's Law (I claim credit).
EVERY MD I've said this to gets irritated, claims that's not true of them. Then they proceed to demonstrate it IS true of them. ALL so far - and I've seen a LOT of doctors in the past 20 years.
I know, I know: they put in unreasonable hours in med school, in Internship, as Residents. Being a doctor is demanding too: half the time they're not even WITH patients, they're doing paperwork for government or insurance companies. I get it.
Here's the thing: as a IT & business consultant I had to keep up with at least 17 different industries & functional areas, stay abreast of developments. I'd never claim I knew as much as my clients about their given functional area, but at very least I had to know enough to be able to vet whether THEY knew their field well. And as soon as I smelled an opportunity, I had to know a LOT more about the given problem than they did. Again: 17+ different industries & functional areas. I had to keep up on them all. So I don't have a lot of time for you if you can't keep up with YOUR sole specialty. And so far, every time I've run up against a life-altering or life-ending medical problem, I've quickly discovered I could know a LOT more about it than my doctors. EVERY TIME SO FAR.
That's irritating, and not just to my doctors.
I've had more than one doctor look at me sideways & say "You understand James, a doctor's worst nightmare is... a patient, with Google."
I'm sorry, you have my sympathy. Just NOT SO MUCH: for you this is irritating. For me, life-threatening!

Unfortunately, we need our doctors. But patients can & SHOULD push back! Demand that your MD keep up. Be humble, realize that they DO have a med degree - you don't - and patients generally can't understand all the stuff they read in medical journals, if they even try. And without an MD's education they can't fit such new stuff into a coherent pattern with the rest of general medical knowledge. Patients face a near-impossible handicap.

OTOH, most doctors aren't even trying. So if you're motivated & somewhat bright, willing to read deeply & research relentlessly, even a patient can often think rings around their specialist. At very least, ask questions & push to have something ruled in or out. Ask whether a given treatment possibility should be considered.
Worst case, you irritate the MD. Worst for you is you'll die, and the MD will... move on. "Oh well, so sad. I'll try to remember that next time I see it." You die; they get to carry on, live a very good lifestyle on a top-5% income.

BE skeptical. Try to be humble, try to be understanding of their plight (8 years+ & $250K in debt as a specialist being second-guessed by an amateur...!"). But be determined, stubborn. Advocate for yourself. Insist on understanding what their position is & why - without that, you can't give informed consent. And 'stick to your guns' (NOT literally) if you think something else is required, or will work better for you. You may not get to choose, but you sure as hell have the right of input, and you can demand they investigate on a best-efforts basis before you provide consent. I don't think that's unreasonable.

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@andyjustin

It’s great to hear that there might be something down the road. It’s better than hearing. As I said, another post, I used gabapentin and pregabalin and I don’t have any qualms with it look my neuropathy is going to be with me for life and it’s gonna get progressively worse and whatever medication it takes to help me function both physically and psychology I accept the fact that pregabalin is addictive gabapentin eventually runs his course and then I’m gonna have to use other drugs to maintain the stability in my life. That being said if it was necessary for me, I’m not against taking opiates. I am against abusing them just my thoughts quickly. Have a great day.

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"my neuropathy is going to be with me for life and it’s gonna get progressively worse."
Not necessarily!
It's a tenet of faith amongst neurologists that "You can't heal nerves! To the extent neurons are damaged, they're done: you can't heal that. You might stop further damage if the problem is something chronic, but you can't heal damage already done."
BS!!
Absolute BS! Ask your Neurologist: "Transplants! What about transplants? Surely if we don't reconnect the nerves from the organ to the body, you'd lose the organ." Hell, we've even seen neurosurgeons give patients who lost a limb, a donor arm from a cadaver! We did it a couple years ago in Toronto, and it wasn't a first world-wide. Patient lost their arm below the elbow in an industrial accident. Two years on & they aren't shuffling cards but they do have feeling & motion, and it's still improving.

I sustained substantial peripheral neuropathy (PN) from a metabolic problem, insulin resistance (think of it as a kind of Diabetes type 2). Solution: stop chronic damage with diet (went on an extreme Keto diet), used a couple of supplements to treat neuronal inflammation (tried everything but only 2 work). It takes many, many months: years. I've identified a bunch of hacks that help. But it DOES work. Worked a charm for me - SLOWLY.

My Neurologist insisted on adding Gapabentin, then when I said 'enough' he switched it to Pregabalin. I don't think it helps at all, will be ditching it.

Since reversing it substantially (though not all) I was diagnosed with cancer. Chemo causes PN - same symptoms, on steroids! - but the mechanism is different. Still, same treatment effected pretty substantial recovery. Then months of Tamoxifen followed: you guessed it, more PN. Again different mechanism but same symptoms. And while I've been switched from Tamoxifen to an aromatase inhibitor, the PN remains a problem.

I should note: just as I've indicated PN can be caused by different medical problems using different mechanisms, it can be caused by lots of other stuff. Heavy metals poisoning, pesticides, herbicides, industrial solvents, viruses (incl. the 'flu & COVID-19), injury (incl. concussions), etc. Some MDs who have heard B12 can help have theorized from this that B12 insufficiency causes it (boy, that's criminally lame reasoning), and B12 &/or B1 can help a little, maybe, but I sincerely doubt it's a common cause.

The most common cause - & certainly mine - appears to be metabolic. We've simply not evolved to live forever on a high-carb diet. We can do it - humans are famously adaptive - but there's fall-out for some people. Not all, but a sizeable percentage of the public.

If that's you, then it all starts with dietary change. If your cause is something different, you'd want to identify what so you can stop it, then see if you can treat the damage. Of course, not everything is likely treatable, but I'd maintain most things are. Hurts nothing to try, right?

Hang in there. Respond to this Comment if you want to know the two supplements: not a secret but they DO each require a hack to work, & this is already a pretty long response. Hang in, heal your nerves, then DO NOT NEGLECT to rub your neurologist's nose (politely) in it: ensure they understand YOU could find a cure - at worst, a treatment - even if they could not. I risked pissing off my neurologist. Did do that, a bit, but got lucky: he's a decent man, more concerned with patient welfare than his damaged ego (he's a find!).

The Neurologist that told me 10 years ago "A doctor's worst nightmare is a patient with Google" has been following my recovery for more than a decade. 8 years ago he started requesting periodic MRIs & whole day-long sessions of cognitive testing, I think to document & correlate changes in imaging (if any) with changes in cognition as tested. Then 2 years ago told me he thought I was onto something: "Don't stop." Like I hadn't noticed. Told me since that he's changed his treatment program at one of Canada's leading teaching hospitals: "Everyone goes on your protocol." Not that he expects it to cure everyone - "Or even anyone." But he was interested to see who it helps. Two years later he's still following his patients, still advocating this treatment approach. He's impatient, but he knows healing nerves takes time. So published studies - all of which are shorter in duration than a few months, not many years - will never show treatment success. They're much too impatient.

I'm grateful to my neurologist: for his character, his willingness to listen (somewhat), follow my success & admit it (wow). He wasn't much help, but he's tried; there just hasn't been much in his kit bag that works 'till now. But he's earned my respect.

Such doctors DO exist. Keep looking for one. And don't stop self-advocating, demanding better care. The supplements & diet you can try on your own, you don't need their assistance (no prescription required). If your problem isn't metabolic but something else, they may still help. The mechanism in most cases is cascading inflammation, in neurons, in the brain & down your nerves. It's all nerve tissue. So the solution is 1) figure out the likely cause (so you can stop it), then 2) address inflammation in neurons. That absolutely IS possible.

A neurologist's assertions that "you can't heal nerves" is just plain wrong, total BS. Ask a neurosurgeon.
Hang in there. I realize it's frustrating. Outlive the bastards, prove them wrong!

REPLY
@jbthompson

Journavx is being marketed for acute (short-term) significant pain. Classic instance would be surgery for broken bones, etc. The phase 2 trial was apparently equivocal, & even it only sought short-term benefit for acute pain. NOT chronic pain.
Severe stenosis? Sorry: they won't be applying for that kind of application until at least after a Phase 3 trial for acute pain.
That doesn't mean your MD can't apply to use it off-label for chronic pain, especially under the Compassionate Care Act if you qualify. But again, that won't likely be a possibility until after a Phase 3 trial reports. That's a few years away, best case.

I do expect there'll be a rush of requests for off-label use, & suspect the pharma company is counting on that. Doctors are under tremendous pressure to reduce their prescription of opioids; patient demand for non-opioid pain meds that work is enormous. I'm sure the pharma company realizes it's sitting on a golden goose & they'd better not F it up by rushing to market, appearing to too obviously game the approvals process, or look too greedy.
If this stuff is relatively side-effect free, not too expensive and actually IS as effective as opiates, there's not only a Nobel prize in store for them, it'll be the blockbuster of the century.

I'm not them - especially not their lawyers - but I'd argue for speedy approval to provide under the Compassionate Care Act free or at very affordable price, on condition that all such use be tracked & outcomes reported meticulously. Such a process would tell the FDA more than even a large Phase 3 trial while demonstrating compassion & concern for patients. And should demonstrate just how amazing such a drug is. They could even supply it free: this kind of program would create more and better data than a Phase 3 trial at a tiny fraction of the cost. No way would such a program cost $20-30 million, and that's the cost of an ineffectually-small phase 2 trial today. A bargain! All while generating market awareness & demand - advertising-free - and generating enormous goodwill. A bargain!

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Its available 600 dollars without a plan actually 500 something

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@jbthompson

Take it up with your MD again. The very fact you're asking for this should indicate to even the slowest-witted MD that you're not an addict: Journavx (Suzetrigine) is NOT an opioid. Won't do a thing for an opiate addict. If your MD thinks you're weaseling opiates by asking for this stuff, he's an idiot.

Jump to this post

Main problem is it’s not covered by any insurance. My spinal pain interventionist said he doesn’t even mention it because only wealthy people can afford it. He stated they do have a program to help with the costs but they want him to write a letter explaining why the patient needs it and they usually deny it anyway.

REPLY
@jbthompson

"my neuropathy is going to be with me for life and it’s gonna get progressively worse."
Not necessarily!
It's a tenet of faith amongst neurologists that "You can't heal nerves! To the extent neurons are damaged, they're done: you can't heal that. You might stop further damage if the problem is something chronic, but you can't heal damage already done."
BS!!
Absolute BS! Ask your Neurologist: "Transplants! What about transplants? Surely if we don't reconnect the nerves from the organ to the body, you'd lose the organ." Hell, we've even seen neurosurgeons give patients who lost a limb, a donor arm from a cadaver! We did it a couple years ago in Toronto, and it wasn't a first world-wide. Patient lost their arm below the elbow in an industrial accident. Two years on & they aren't shuffling cards but they do have feeling & motion, and it's still improving.

I sustained substantial peripheral neuropathy (PN) from a metabolic problem, insulin resistance (think of it as a kind of Diabetes type 2). Solution: stop chronic damage with diet (went on an extreme Keto diet), used a couple of supplements to treat neuronal inflammation (tried everything but only 2 work). It takes many, many months: years. I've identified a bunch of hacks that help. But it DOES work. Worked a charm for me - SLOWLY.

My Neurologist insisted on adding Gapabentin, then when I said 'enough' he switched it to Pregabalin. I don't think it helps at all, will be ditching it.

Since reversing it substantially (though not all) I was diagnosed with cancer. Chemo causes PN - same symptoms, on steroids! - but the mechanism is different. Still, same treatment effected pretty substantial recovery. Then months of Tamoxifen followed: you guessed it, more PN. Again different mechanism but same symptoms. And while I've been switched from Tamoxifen to an aromatase inhibitor, the PN remains a problem.

I should note: just as I've indicated PN can be caused by different medical problems using different mechanisms, it can be caused by lots of other stuff. Heavy metals poisoning, pesticides, herbicides, industrial solvents, viruses (incl. the 'flu & COVID-19), injury (incl. concussions), etc. Some MDs who have heard B12 can help have theorized from this that B12 insufficiency causes it (boy, that's criminally lame reasoning), and B12 &/or B1 can help a little, maybe, but I sincerely doubt it's a common cause.

The most common cause - & certainly mine - appears to be metabolic. We've simply not evolved to live forever on a high-carb diet. We can do it - humans are famously adaptive - but there's fall-out for some people. Not all, but a sizeable percentage of the public.

If that's you, then it all starts with dietary change. If your cause is something different, you'd want to identify what so you can stop it, then see if you can treat the damage. Of course, not everything is likely treatable, but I'd maintain most things are. Hurts nothing to try, right?

Hang in there. Respond to this Comment if you want to know the two supplements: not a secret but they DO each require a hack to work, & this is already a pretty long response. Hang in, heal your nerves, then DO NOT NEGLECT to rub your neurologist's nose (politely) in it: ensure they understand YOU could find a cure - at worst, a treatment - even if they could not. I risked pissing off my neurologist. Did do that, a bit, but got lucky: he's a decent man, more concerned with patient welfare than his damaged ego (he's a find!).

The Neurologist that told me 10 years ago "A doctor's worst nightmare is a patient with Google" has been following my recovery for more than a decade. 8 years ago he started requesting periodic MRIs & whole day-long sessions of cognitive testing, I think to document & correlate changes in imaging (if any) with changes in cognition as tested. Then 2 years ago told me he thought I was onto something: "Don't stop." Like I hadn't noticed. Told me since that he's changed his treatment program at one of Canada's leading teaching hospitals: "Everyone goes on your protocol." Not that he expects it to cure everyone - "Or even anyone." But he was interested to see who it helps. Two years later he's still following his patients, still advocating this treatment approach. He's impatient, but he knows healing nerves takes time. So published studies - all of which are shorter in duration than a few months, not many years - will never show treatment success. They're much too impatient.

I'm grateful to my neurologist: for his character, his willingness to listen (somewhat), follow my success & admit it (wow). He wasn't much help, but he's tried; there just hasn't been much in his kit bag that works 'till now. But he's earned my respect.

Such doctors DO exist. Keep looking for one. And don't stop self-advocating, demanding better care. The supplements & diet you can try on your own, you don't need their assistance (no prescription required). If your problem isn't metabolic but something else, they may still help. The mechanism in most cases is cascading inflammation, in neurons, in the brain & down your nerves. It's all nerve tissue. So the solution is 1) figure out the likely cause (so you can stop it), then 2) address inflammation in neurons. That absolutely IS possible.

A neurologist's assertions that "you can't heal nerves" is just plain wrong, total BS. Ask a neurosurgeon.
Hang in there. I realize it's frustrating. Outlive the bastards, prove them wrong!

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Please tell me what the 2 supplements are that can help PN. I developed AIDP as a complication of covid. It is so painful.

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@flyjim

Main problem is it’s not covered by any insurance. My spinal pain interventionist said he doesn’t even mention it because only wealthy people can afford it. He stated they do have a program to help with the costs but they want him to write a letter explaining why the patient needs it and they usually deny it anyway.

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I have Medicare and after my doctor wrote for prior authorization they did approve it but I think it's easier to get approved with Medicare.

REPLY
@jbthompson

Journavx is being marketed for acute (short-term) significant pain. Classic instance would be surgery for broken bones, etc. The phase 2 trial was apparently equivocal, & even it only sought short-term benefit for acute pain. NOT chronic pain.
Severe stenosis? Sorry: they won't be applying for that kind of application until at least after a Phase 3 trial for acute pain.
That doesn't mean your MD can't apply to use it off-label for chronic pain, especially under the Compassionate Care Act if you qualify. But again, that won't likely be a possibility until after a Phase 3 trial reports. That's a few years away, best case.

I do expect there'll be a rush of requests for off-label use, & suspect the pharma company is counting on that. Doctors are under tremendous pressure to reduce their prescription of opioids; patient demand for non-opioid pain meds that work is enormous. I'm sure the pharma company realizes it's sitting on a golden goose & they'd better not F it up by rushing to market, appearing to too obviously game the approvals process, or look too greedy.
If this stuff is relatively side-effect free, not too expensive and actually IS as effective as opiates, there's not only a Nobel prize in store for them, it'll be the blockbuster of the century.

I'm not them - especially not their lawyers - but I'd argue for speedy approval to provide under the Compassionate Care Act free or at very affordable price, on condition that all such use be tracked & outcomes reported meticulously. Such a process would tell the FDA more than even a large Phase 3 trial while demonstrating compassion & concern for patients. And should demonstrate just how amazing such a drug is. They could even supply it free: this kind of program would create more and better data than a Phase 3 trial at a tiny fraction of the cost. No way would such a program cost $20-30 million, and that's the cost of an ineffectually-small phase 2 trial today. A bargain! All while generating market awareness & demand - advertising-free - and generating enormous goodwill. A bargain!

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Not sure if that would touch the bone pain I have with these WBC booster shots I get after chemotherapy. I already take hydrocodone for severe back issues and the ER morphine 15mg every 12 hours. As soon as my treatments end I'll stop the morphine. I had chemo on the 9th, Monday, and the bone pain starts about 2 days after and lasts about 5 days. It did with my 4th treatment. Both legs hurt from groin to ankles. If I knew without a doubt this new med would treat my pain, I might try it. I've been on hydrocodone for 20 years though. It still works as it did when I started it. I take it every 6 hours, every 4 when I need it but that's only about once a month. This bone and cancer pain is horrible though so I'd need something I knew worked without risking my sanity. Lol

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