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107

FDA approves new type of nonopioid painkiller for acute pain (www.nbcnews.com)

submitted 1 year ago by return2ozma@lemmy.world to c/news@lemmy.world

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[–] Catoblepas@lemmy.blahaj.zone 39 points 1 year ago* (last edited 1 year ago) (4 children)

In phase 3 clinical trials by the drugmaker, researchers looked at how well the drug worked after surgery. Patients who had undergone either tummy tucks or bunion surgery were given either suzetrigine every 12 hours; an opioid, hydrocodone, plus Tylenol every six hours; or a placebo for 48 hours after the operations.

[ . . . ]

The dose of hydrocodone was also smaller than what is typically given after surgery, “so it’s hard to know exactly what to make of the results,” Rind said.

🚩🚩🚩

I’m not saying this is 100% what it is, but if I wanted to make a less effective drug look more effective, then comparing its performance to a smaller than normal dose of an approved drug would be one way to do it.

If it’s actually effective then that’s great, there are people that need non-opiate alternatives. My worry is that it’s not and this is going to wind up being another way patients in acute pain get told to suck it up and deal by their doctors.

[–] janNatan@lemmy.ml 14 points 1 year ago (3 children)

They seriously gave people a placebo for pain after surgery? That sounds horrible.

[–] plz1@lemmy.world 10 points 1 year ago (1 children)

The people volunteered. You don't get into a drug trial without informed consent.

[–] Buddahriffic@lemmy.world 2 points 1 year ago

Without reading any study information, I bet in studies like these, there's a way to opt out and be given a proven one (at least assuming there aren't concerns about how they'd interact with the experimental ones, though I'd also expect those to be understood from the safety studies).

The opt out option wouldn't even make that participant's contribution worthless because someone begging to no longer do the study would be a good indicator that the pain med isn't working well. "Time between administering drug and requesting exit from study" could even be used as an indicator to see if there's any significant difference between the placebo and study drug, where the proven painkiller group acts as the control instead of the placebo group.

Though I don't know how these studies account for different pain tolerance levels and different amounts of pain from the procedure, which could even vary for people getting the exact same procedure, since there will be variance between exact location of cuts and such. There would probably be some placebo group members that won't complain of pain and proven painkiller group members that do complain (some just wanting more drugs, some experiencing pain, imagined or real, and some behaving as if they are in pain despite not feeling it).

[–] Fluke@discuss.online 3 points 1 year ago

Everyone in all groups also had an NSAID

[–] Canadian_anarchist@lemmy.ca 1 points 1 year ago (1 children)

That's what a control group is. All participants are given the information upfront about the study parameters, called informed consent. Participants can leave a study at anytime.

No one forced them to participate.

[–] janNatan@lemmy.ml 1 points 1 year ago

They consented to something that sounds horrible. None of that changes the fact that it sounds horrible.

[–] HubertManne@moist.catsweat.com 8 points 1 year ago

bunions and tummy tucks? I want to know how it will be after a knee realignment!

[–] Fluke@discuss.online 7 points 1 year ago

The placebo control is key, and it was at least statistically better than placebo.

You're right that it's hard to tell if it is more or less effective than hydrocodone+acetaminophen but it's good news either way because it can potentially reduce the use of opioids and be another option.

[–] lennivelkant@discuss.tchncs.de 5 points 1 year ago

so it’s hard to know exactly what to make of the results

Sounds like someone desperately trying to not ruin future grant chances by saying "this trial is absolutely worthless"...

[–] Nosavingthrow@lemmy.world 21 points 1 year ago (3 children)

10000% there are side effects that they know about and will hide. I'm willing to place my honor as a gentleman on the line.

[–] Fluke@discuss.online 5 points 1 year ago

History and the motivation to make money say you're spot on. Despite that, I'm still happy to be opening up new pathways for pain reduction. I'm hoping for the best for this and other options.

[–] MintyFresh@lemmy.world 4 points 1 year ago

There will be whigs on the lawn I say!

[–] Buddahriffic@lemmy.world 3 points 1 year ago

Imo all safety studies should be duplicated, with one run by someone that wants the study to give a safe and effective conclusion and another run by someone who wants the study to give a dangerous or ineffective conclusion. Both studies monitored by neutral parties that are rewarded based on how long the studies stand up for. And no NDAs (or at least no NDAs that don't expire once the product hits the market) so that all three can be vocal about any issues they had with how the others wanted things run.

And criminal charges for any kind of corruption.

[–] gashead76@lemmy.world 18 points 1 year ago (2 children)

I have chronic pain and I'm all for innovation in the realm of pain management, but I personally won't even think about taking that drug for many, many years. Fucking with sodium channels sounds super dangerous. There are so many variables they just could not have tested or even guessed at. It also doesn't help that if there's an adverse reaction to be had, I'm gonna have it.

[–] Xanthobilly@lemmy.world 10 points 1 year ago (1 children)

It targets a sodium channel that only exists in pain neurons, called NAV1.8, or SCN10A. It’s not found elsewhere in the body. The whole reason this research is exciting is because it would be so specific it wouldn’t have the side effects seen with opioids or any anesthetic for that matter—central depression, which is what causes your breathing to stop.

[–] gashead76@lemmy.world 3 points 1 year ago

It is very interesting and amazing stuff, no doubt about that. The future of medicine is only going to get more amazing, but I suppose I just really have very little confidence in that space because of a lack of understanding in oddball humans like myself who have somewhat bizarre physiology. For the vast majority of people, I think having a pain medication that doesn't also slowly kill you is obviously a net positive.

[–] Fluke@discuss.online 10 points 1 year ago (2 children)

I'm with you. A good 5+ year lag after FDA approval is a good idea if that's an option. That being said, the FDA is generally good with drug safety and these studies look good.

[–] halcyoncmdr@lemmy.world 10 points 1 year ago

FDA is generally good with drug safety

Just you wait until RFK Jr is all up in that FDA pipeline. You think the brain worm controlling his corpse is going to just sit at the head of HHS and not try to force changes wherever he can remotely pry?

[–] gashead76@lemmy.world 4 points 1 year ago

I definitely look forward to a future where I might not have to consume NSAIDS like candy anymore, because those are definitely doing some real damage.

[–] sudo42@lemmy.world 11 points 1 year ago

This new pain med is totally non-addictive. I mean trust us. Totes.

[–] greedytacothief@lemmy.world 10 points 1 year ago

The drug might suck. But I think continuing research on non opioid pain killers is probably a good thing.

[–] winkly@lemmy.world 7 points 1 year ago

no no pioids tsk tsk