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Medicine

FDA Approves Drug To Treat Pain Without Opioid Effects (apnews.com) 82

Posted by BeauHD from the modestly-effective dept.
Bruce66423 shares a report from the Associated Press: Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications such as Vicodin and OxyContin. "It's the first new pharmaceutical approach to treating pain in more than 20 years, offering an alternative to opioids and over-the-counter medications such as ibuprofen and acetaminophen. But the medication's modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage pain.

Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex's drug provided more relief than a dummy pill but didn't outperform a common opioid-acetaminophen combination pill. "It's not a slam dunk on effectiveness," said Michael Schuh of the Mayo Clinic, a pharmacist and pain medicine expert who was not involved in the research. "But it is a slam dunk in that it's a very different pathway and mechanism of action. So, I think that shows a lot promise." The new drug will carry a list price of $15.50 per pill, making it many times more expensive than comparable opioids, which are often available as generics for $1 or less. [...]

Opioids reduce pain by binding to receptors in the brain that receive nerve signals from different parts of the body. Those chemical interactions also give rise to opioids' addictive effects. Vertex's drug works differently, blocking proteins that trigger pain signals that are later sent to the brain. "In trying to develop medicines that don't have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain," Vertex's Dr. David Altshuler, told The Associated Press last year. Commonly reported side effects with the drug were nausea, constipation, itching, rash and headache.

FDA Approves Drug To Treat Pain Without Opioid Effects More | Reply

FDA Approves Drug To Treat Pain Without Opioid Effects

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  • Sounds Great (Score:3)

    by CoolDiscoRex ( 5227177 ) on Friday January 31, 2025 @10:26PM (#65134119) Homepage

    Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertexâ(TM)s drug provided more relief than a dummy pill but didnâ(TM)t outperform a common opioid-acetaminophen combination pill.

    Wait, it outperformed a tic-tac? I am sold, gimme two of them!

    • Can somebody loan me thirty bucks?

    • "Common opioid-acetaminophen combination pill" could mean Norcos or Tylenol 3s (acetaminophen plus either codeine or hydrocodone). You think those are like tic-tacs? This is damn good news if they found something that is equally effective and non-addictive. And since it's a novel mechanism of action, the efficacy might improve with the next generation.

      • Re:Sounds Great (Score:5, Interesting)

        by Retired Chemist ( 5039029 ) on Friday January 31, 2025 @11:07PM (#65134179)
        Apparently, they found it to be about as effective as Tylenol 3. It uses a different mechanism than opioids to block pain, so the mechanism that causes opioid addiction should not be active. It remains to be seen how addictive it might be in long term use. Looking at the structure (https://en.wikipedia.org/wiki/Suzetrigine), I am not surprised at the price. This is not a cheap or easy molecule to make.

      • Re: (Score:2)

        by ufgrat ( 6245202 )

        Unless your liver lacks the enzyme necessary to activate the various opioids such as codeine, *codone, *contin, etc. Then it's just acetaminophen, which is, the last I checked, the primary cause of liver failure in the USA.

      • Yeah but look at its real feature, it costs fifteen times as much as the alternatives. The pharma/HMO/whatever industry in the US will love it. Get ready to see the bills on your insurance statements the minute they approve it.

      • could mean Norcos or Tylenol 3s (acetaminophen plus either codeine or hydrocodone). You think those are like tic-tacs?

        Paracetemol with codeine is available over the counter in the UK and although the chemist will not hand them out quite like tic-tacs you do not need a prescription. If this pill is less effective and more expensive than this then I'm not sure it is much of a benefit especially since rather than "non-addictive" I'd tend to classify it more as "not yet shown to be addictive" given that the industry has repeatedly come up with "non-addictive" drugs that are later shown to be addictive.

        • Paracetemol with codeine is available over the counter in the UK and although the chemist will not hand them out quite like tic-tacs you do not need a prescription

          Canada is the same (although it is Tylenol with Codeine on this side of the pond). You can also get cough medicine with Codeine from the pharmacist without a prescription.

          ...and they should NOT be taken over the US border. The puritans south of the 49th parallel do not look kindly on opiate drugs (no matter how small the dose) without a presc

        • Really? Wow, didn't know that. Codeine is converted in the liver to plain old morphine (although some people are better at converting it than others). If you take enough, it's definitely addictive, and I've met people who abused it.

          There's a difference in potency between codeine and hydrocodone, which is why it's a shame TFS wasn't more specific about which "common" pill they were comparing it to. Potency is usually expressed in "morphine equivalents"-- 10 mg of hydrocodone is equal to 10 mg of morphine

          • If you take enough, it's definitely addictive, and I've met people who abused it.

            Yes it is but it the dose is small, there are warnings not to take for for more than 3 days in a row without a doctor's advice and because it comes with paracetemol you can't just keep popping the pills. Given this the risk of addication is vanishingly small and I would argue less than that of alcohol which is far more easily obtained and with far fewer controls and there are lots of people who abuse it.

      • Common opioid-acetaminophen combination pill" could mean Norcos or Tylenol 3s (acetaminophen plus either codeine or hydrocodone). You think those are like tic-tacs? This is damn good news if they found something that is equally effective and non-addictive.

        Let us read it again. Slowly this time.

        Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex's drug provided more relief than a dummy pill but didn't outperform a common opioid-acetaminophen combination pill.

        • "Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex's drug provided more relief than a dummy pill but didn't outperform a common opioid-acetaminophen combination pill."

          "Did not outperform X" is assumed here to be equivalent to saying "efficacy was not statistically different from X".

          If the new medication appears to have therapeutic efficacy *equivalent* to a that of a Norco or a Tylenol 3, and the new medication is thought to be non-addictive-- and uses a nov

          • It just has to be equivalent to a Norco to be impressive.

            Since they said it is not equivalent then I'm not impressed. They gave such a wide range on effectiveness that it could be interpreted as no better than Tylenol to just short of Norco.

            But what do I know, I've only been treating opioid addicts and chronic pain patients for twenty years.

            How can you tell the difference between the two?

            The claim is that people fake chronic pain all the time just so they can get high, or sell the drugs they are prescribed to people that want to get high. If that's the case then there must be some clues on finding those with real pain vs. the addicts faking it.

            I don't know why

            • It just has to be equivalent to a Norco to be impressive.

              Since they said it is not equivalent then I'm not impressed. They gave such a wide range on effectiveness that it could be interpreted as no better than Tylenol to just short of Norco.

              No, you're quite correct there, they don't explicitly say "X is as good as Y". What they say is "X *did not outperform* Y". From a strictly logical standpoint, that could be interpreted to mean either "X was about as good as Y" or "X was not nearly as good as Y". But I'm assuming that the writer of the summary was reasonably intelligent and guessing that they meant option #1. (See previous post). If it's option #2, that would be a weird/confusing way to express it. (If someone can find the actual resea

      • It doesn't say it's equally effective.

    • You might be surprised at how good placebos are at fixing things. Then there's hypnosis which is even better. If you need pain killers, try hypnosis first. There's no negative side effects and it's a skill you'll be able to maintain for your entire life. Hypnosis is used during extensive surgeries when a patient has an issue with the normal pain killers. Granted doing it at that level requires a lot more prep work, but you're probable not getting your chest cut open.

      Just think about it for a moment. I

  • Meanwhile (Score:4, Informative)

    by ArchieBunker ( 132337 ) on Friday January 31, 2025 @10:47PM (#65134147)

    Cannabis is still a schedule 1 substance.

    • Cannabis is still a schedule 1 substance.

      Fetanyl is a schedule 2 substance. Figure that one out.

      Being listed as schedule 1 is supposed to mean that a drug has no known medical use, is highly addictive, and blah blah blah. Schedule 2 indicates that a drug has a known medical use but because of its highly addictive nature it must be prescribed with great care, which is often interpreted as it is only dispensed in a hospital.

      Oh, a side note, cocaine is also schedule 2. That means cocaine has a known medical use. While I expect cannabis to be resc

      • Re: (Score:2)

        by jbengt ( 874751 )

        I don't know why that physician I saw didn't just write a prescription for Mucinex, even if a prescription isn't required a physician can write a prescription for any drug. I got prescriptions for ibuprofen in the Army . . .

        Indeed, I was given a prescription for high dose vitamin D to be taken once a week. Then, later, my doctor told me that if insurance didn't pay for it, it might be cheaper to just by the over-the-counter bottle and take multiple pills. It was, so I did.
        My daughter is a dentist and of

      • Oh, a side note, cocaine is also schedule 2. That means cocaine has a known medical use.

        It does. It's quite a powerful analgesic when you administer it to the spine. Here [youtu.be] is a British doctor explaining it in a not-terrible German accent, recounting a case study from the late 1800s. Horrible side-effects not withstanding there are obvious reasons for it not being used for pain management any more.

      • Make laudanum legal again!

        What makes you think that it isn't? In the US, at least, laudanum [wikipedia.org] is available by prescription only, and it's on Schedule II, the second strictest category.

      • Re: (Score:2)

        by olddoc ( 152678 )
        Cocaine does have a medical use. I work as an anesthesiologist and see a lot of Ear Nose and Throat cases. 4% cocaine is used as a local anesthetic that also cuts down on blood loss by constricting blood vessels in the nose. Cocaine could be replaced by lidocaine and epinephrine or phenylephrine, but the surgeons I work with seem to like it. Patients are under general anesthesia when cocaine is applied so they don't experience the "rush" and I can not see any effects in the recovery room after. Cocaine is a

        • I wasn't arguing for the rescheduling of cocaine, or of fentanyl either. I was thinking more of codeine, morphine, hydrocodone, and perhaps other similarly potent opiates.

          In many countries around the world Tylenol 3 and/or similar blends of codeine/acetaminophen are available over the counter, and I believe it not too much to ask for the USA to do the same. Cough syrups including various blends of opiates and other active ingredients should also be over the counter. When it comes to prescribing more pote

      • Re: (Score:2)

        by sjames ( 1099 )

        Cocaine is used for at least one medical test and is used in ENT surgery to control both pain and bleeding. Both are topical applications.

        As for pseudoephedrine, the icing on the cake is that the ingredient that replaced it in most cough and cold medicines has been shown to be no more effective than placebo.

  • $15 Per Pill (Score:4, Interesting)

    by sound+vision ( 884283 ) on Friday January 31, 2025 @10:49PM (#65134155) Journal

    For some perspective, $15/tablet is roughly the street price of Vicodin. Or the per-hit price of heroin, both opiates. Although the "heroin" available now is mostly fentanyl. (So is the Vicodin, unless you get it directly from a pharmacy.)

    The article didn't tell me anything about how the new meds work. It did mention side-effects of "nausea, constipation, itching" - these sound suspiciously similar to opiate side-effects, the last 2 in particular are fairly unique to opiates.

    The summary calls these new meds "non-abusable", but that's the same thing the industry said when OxyContin was released, and gabapentin. You must excuse me if I don't take these assertions at face value.

    • Oxycontin was never claimed to be non-abusable because of its chemical formula, only by its time-release formulation. But people easily found ways to circumvent that. So this new claim is of a different nature.

      • Only a drug dealer would claim Oxy is not abusable.

        • Most everything is addictive.

          There's people that get addicted to eating the foam out of couch cushions. I don't recall what is addictive about it but there has apparently been many cases documented of this happening. I assume the foam isn't toxic or people would be dead than addicted. If there's a drug that causes some kind of physical or mental effect then that can most certainly be addicting to some not insignificant portion of the human population. If there's a substance that doesn't cause any physic

        • Yes, that claim was proven wrong, and quickly too. Just pointing out that doesn't necessarily mean that's the fate of every other drug that comes along from now until forever.

    • Anything that stops pain is going to be addictive... no one will want to stop if it means being in pain... and other than that, how does one define addictive?

      Addiction is simply something someone else refuses to stop doing... so this will be addictive regardless of what they think any specific mechanism is that causes addiction.

      • how does one define addictive?

        That's a good question.

        Addiction is simply something someone else refuses to stop doing...

        No, it is a harmful activity that someone refuses to stop doing that defines addiction. If it's just habit then I'm addicted to oxygen, water, and Frosted Flakes. Well, maybe I am addicted to Frosted Flakes but I'm not addicted to water and air.

        If this is narrowed to taking drugs out of habit then my sister is addicted to insulin. She has diabetes so she takes insulin regularly. Since taking this drug is not considered harmful then it's not considered an addiction.

        If this is about

        • But who considers it harmful...

          If I think using insulin to stop diabetes is harmful, and she should suffer according to god's plan, then she is a drug addict.

          On the other hands, addicts, of their own free will spend their own hard earned money on drugs, clearly they think the benefits outweigh the costs (from revealed preferences) and so are not addicted.

          Remove the subjective evaluation of other people's habits from your definition because otherwise we are back where we started that addiction is just other

          • Remove the subjective evaluation of other people's habits from your definition because otherwise we are back where we started that addiction is just other people's opinion you shouldn't be doing stuff.

            If we remove the requirement that a habit is harmful then the taking of a daily vitamin supplement is an addiction that needs to be punished, treated, or whatever.

            How else can you define an addiction other than it posing some harm or danger? Or more specifically a harm or danger not outweighed by the benefits? Of course that is subjective, and that's the problem we (as a species) have been facing for centuries, if not millennia.

            • Well exactly, why assume that addicts are irrational, rather than assuming they are utility maximising economic agents like everyone else and are acting like they are doing whatever maximises their own subjective value.

              No one pays $100 for something that's not worth $100 to them, why would we assume addicts are any different?

              Every choice has costs and benefits... the idea they are doing something harmful is simply recognising there are costs...

              The very concept (outside of very narrow application) seems wild

    • Re:$15 Per Pill (Score:5, Informative)

      by az-saguaro ( 1231754 ) on Saturday February 01, 2025 @03:54AM (#65134423)

      Hopefully this will answer some of your questions.

      Opioids work by binding to opioid receptors in the CNS (central nervous system). They are remarkably good pain killers with several serious side effects:
      - they depress respiration - stop it and cause death if enough is taken.
      - they cause addiction and its many related problems.
      - they cause serious constipation or ileus - not in the same severity league as the other two, but problematic in select cases.
      - minor allergy symptoms such as itching, and other incidental side effects are the same as any drug.

      Used properly, such as for post-operative pain relief, they are they only dependable class of drugs to date that make surgery reliably tolerable - AND - they do not have the serious side effect risks as above when prescribed and used properly - which is most of the time.
      The big problem today is the "institutional" abuse form illicit drug traffickers and from the few nominally licit drug manufacturers who fucked this all up the circa 1995-2005.

      As evidenced by the comments here, many people now only know about the bad news of narcotics, but without them, surgery and other good medical care could not be done as we now take for granted.
      So - no dissing on narcotics - because most of its medical usage is legitimate, safe effective.

      We know vast amounts about how narcotics work, affect brain chemistry and function, etc. There is inherent biology and chemistry that makes it hard to engineer a narcotic or analogue that remains effective at lower risks - those effects are coupled. SO - there is clearly a need and a desire for substitute drugs that are effective without such risks.

      We have effective drugs.
      We have safe drugs.
      But, we do not have safe drugs sufficiently effective for pains where narcotics are best - short term after surgery, trauma, and during surgery-anesthesia. That is why this is not a trivial problem.

      Enter - suzetrigine, the compound in this article.
      It is a new drug ion the market, but it is not a new class of drugs.

      It is a sodium channel blocker.

      Excitable tissues are those that generate, conduct, or are triggered by electricity - nerves and muscles. They regulate everything in the brain, heart, blood vessels, bowels, bronchi, etc. Cells and tissues do not have copper wires to conduct current. They depend on movement and exchange of ions to carry an electric field. Sodium and potassium are key, regulated by calcium. Excitable cells (muscle and nerve) use energy to pump Na+ and K+ to either side of cell membranes. These ions are exchanged through protein pores in the cell membranes called ion channels. They keep Na on the outside, K on the inside. This energy absorbing separation of charge is essentially the battery that will energize the system when the right "switch" is thrown. Both of the separated ions want to "fall" into their concentration gradients, and when a valid stimulus comes along, the pores open and allow the sudden exchange of the highly separated Na/K. This depolarization causes a current in the cell that propagates along the membrane, triggering adjacent channels to open, and the depolarization, in essence the ionic current to propagate. It is an amazing process. In long peripheral nerves, the axons, the "wires" that the nerves make to conduct these ionic currents are long, in humans approximately a meter long from spinal cord to distal extremities with propagation-conduction times of about 2 milliseconds.

      One way to stop pain or any electrical activity in nerve and muscle cells is to block the ion channels or the pumps that separate charge through the channels. we have drugs that can block sodium channels, potassium channels, calcium channels. Many have been around a very long time, long before we even know how they worked. Now, we engineer man new drugs to block these channels. They are used for to calm down overly-excitable tissues, in essence to weaken them or filter their effects ("filter" in the sense of blunt peak effects or d

      • Re: (Score:2)

        by Nkwe ( 604125 )
        No mod points today, so I can't tag informative or insightful. Thank you for this post. I learned a lot.

      • Re: (Score:2)

        by e3m4n ( 947977 )

        Had too many fellow vets get hooked on pain pills and graduated to needles. I will suffer through it with a combination of Tylenol and motrin. Its just not worth the gamble. It cant be worse than the burning feeling after getting shot. At least I dont think so.

    • Re: (Score:2)

      by jbengt ( 874751 )

      The summary calls these new meds "non-abusable", but that's the same thing the industry said when OxyContin was released, and gabapentin. You must excuse me if I don't take these assertions at face value.

      No excusing needed. Bayer originally pushed their heroin as a less-addictive substitute for opium and morphine.

  • they'll find it is addictive after all, but they will have made billions by then so who cares

    (Of course WHO are no longer involved since Trump kicked them out.)

  • Even aspirin (paracetamol) is dangerous when taking too much. Many brands are available in 1000mg (1g) pills over the counter, which adults shouldn't take more than one every 6 to 8 hours. Little known detail: 10g in 24 hours can be lethal, barely 3x the maximum dose. The liver may give in after a day, without clear pains and discomfort to signal impending death, until it's too late. All these chemicals are not to be trifled with. Let's hope this new one really does have few side effects. Pain can be really

  • but didn't outperform a common opioid-acetaminophen combination pill,

    Tylenol 4 is fucking amazing. Even Tylenol 3 isn't bad, although if your stomach can't tolerate much acetaminophen it's not for you. There is a synergistic effect that works on pretty much any kind of pain. Allowing someone to go home with a bunch of them is probably a pretty big mistake, but they provably work.

    Commonly reported side effects with the drug were nausea, constipation, itching, rash and headache.

    Anything that commonly causes headache isn't a good pain reliever.

  • killer than I am about some doctor or hospital's medical malpractice insurance payments.

    They already greatly under prescribe painkillers at this point thanks to the Purdue lawsuits and others.

  • Normal life is full of aches and pains. Take those away, or mute them to near silence, and the brain gets used to that. Addicted to it.

    Hence, rebound pain. Hence, addiction.

    We need pain relief - post surgery for example - but magical addiction free pain relief is likely impossible.

    • We need a biochemist or doctor to weigh in on this one. Because I thought the addictive properties of opioids go way, way beyond the simple pain relief effect. I think youre wrong when you say rebound pain is the whole reason for addiction.

      • We need a biochemist or doctor to weigh in on this one. Because I thought the addictive properties of opioids go way, way beyond the simple pain relief effect. I think youre wrong when you say rebound pain is the whole reason for addiction.

        I doubt it's the whole reason. But yeah, I think it's a big reason.

  • Firstly, I almost died because Stanford wanted to try something else for pain, other than opioids. After having collapsed my lung for the second time, a doctor at Stanford wanted to try gabapenten for pain. I only found out that I was having a reaction to it--when I was driving home on 101--with no where to pull over.

    I am still in pain, today. I have not had a recovery. I will likely be in pain for the rest of my life. I regret going to Stanford for my lung problem.
  • No, people were never supposed to take street-fentanyl. Fentanyl, a surgical pain reliever was never supposed to be sp popular street drug--it's in a spell checker. The stubborn fact remains: opiates relieve pain better than anything else--because that is how we are made. The other fact that other people forget: people are in pain, and because of marketing and street opiates--people who are in pain, cannot get pain relievers.

  • And Europe and Asia keep screaming in pain because opioids are not an option in most places there exept for terminal diseases. Or maybe the "secret" of non-opium derived painkillers isn't really much of a secret.

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