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FDA approves intranasal esketamine formulation
- mabbo 8y agoThere's an interesting risk to all of this: legitimizing the illegal drug. Let's say my doctor says to me "you're depressed, I'm prescribing esketamine, go to this clinic and pay them $3000". Well, I do my research and learn that really this stuff has the same antidepressants effect as ketamine. And the same number of doses of ket on the darknet markets are going to cost me a heck of a lot less. Sure, there's the question of legality. But if I can't afford esketamine but can afford dodgy internet ket, and I'm desperate for something, anything, to help with this nagging constant psychic pain weighing down my life... Suddenly I appreciate my Canadian single payer health care system a lot more, even with the small problems it has.
- deleted 8y ago[deleted]
- jmcgough 8y agoMost people probably lack the technical aptitude to use darknet markets, so this is probably more relevant to hacker news readers than the general public.
- loeg 8y agoWhat's the risk of legitimizing ketamine? The majority of the research and meta-reviews support ketamine as a treatment for depression too. The S-isomer may be better in some ways, but maybe not $3k better if you're poor. On a risk/harm scale, it's comparable to alcohol or cigarettes[1]. [1]: https://en.wikipedia.org/wiki/Drug_harmfulness#/media/File:Development_of_a_rational_scale_to_assess_the_harm_of_drugs_of_potential_misuse_(physical_harm_and_dependence,_NA_free_means).svg https://en.wikipedia.org/wiki/Drug_harmfulness#/media/File:D...
- fucking_tragedy 8y agoWhen you get ketamine from a doctor, it is in metered in sub-psychedelic and sub-anesthetic doses. When you get ketamine from the internet, you're getting a mystery powder that is, at best, a potent form of an addictive drug in quantities that are not metered and are ripe for abuse. At worst, you're getting some form of fentanyl because internet drug dealers are inept.
- loeg 8y agoYou have a lot of opinionated adjectives in that second sentence that aren't related to the chemical, which is the same one as in the first sentence. > a potent form of an addictive drug It's literally the same chemical; you didn't use those adjectives when you described it earlier. > quantities that are not metered Readily fixed for < $20: https://www.amazon.com/dp/B07D1NNGM6/ https://www.amazon.com/dp/B07D1NNGM6/ https://erowid.org/chemicals/ketamine/ketamine_dose.shtml#oral https://erowid.org/chemicals/ketamine/ketamine_dose.shtml#or... > At worst, you're getting some form of fentanyl because internet drug dealers are inept. That's not a ketamine problem; it's a prohibition problem.
- fucking_tragedy 8y ago> It's literally the same chemical; you didn't use those adjectives when you described it earlier. I would talk the same way about treating ADHD with Desoxyn prescribed by a doctor versus buying a pile of methamphetamine online to self-medicate with. > Readily fixed for < $20: https://www.amazon.com/dp/B07D1NNGM6/ https://www.amazon.com/dp/B07D1NNGM6/ If you're going to make bad choices, volumetric dosing is one of the less bad choices. > That's not a ketamine problem; it's a prohibition problem. It's a regulation problem. The supplement market is full of bunk or outright fake products. It took the FDA to reel actual medicine in.
- mzybert 8y ago> Readily fixed for < $20: https://www.amazon.com/dp/B07D1NNGM6/ https://www.amazon.com/dp/B07D1NNGM6/ My friend had one like this. It was barely accurate enough for all the funny RCs we had.
- Alex3917 8y agoKetamine isn't an illegal drug, it's been FDA-approved for decades. They're both schedule III.
- AstralStorm 8y agoIt was not legal to prescribe as an antidepressant outside experimental setting.
- Broken_Hippo 8y agoProbably not directly, but I'm pretty sure it is legal to prescribe medicines for off-label use as well. Is there some sort of restriction on this particular drug that I'm not aware of?
- irq 8y agoThis is completely wrong. For quite a long time it has been legal for doctors to prescribe FDA approved drugs off-label, that is, for reasons other than what they're FDA approved for. But if it's not FDA approved, insurance companies won't pay for it. That's what this ruling changes, for this one form of the drug.
- vilhelm_s 8y agoAlthough that's not necessarily true either. Insurance contract typically pay for FDA-approved indications, but they also usually have some process where they will pay for off-label use if you can submit evidence that it's scientifically justified and cheaper alternatives would not work. Of course this is pretty stressfull, but it's really necessary in the U.S. because getting FDA to approve a new indication is really expensive for the drug companies, so there are a lot of drugs which are not approved for some of their main uses. For example, SSRIs are commonly used for anxiety even though this is off-label.[1] And monoclonal antibody-based immunosuppressives like adalimumab are often only approved for a few conditions, like Crohn's and arthritis, even though they are useful for auto-immune diseases in general. In the specific case of ketamine for depression, some people do seem to have successfully gotten insurance companies to pay for it.[2] Even without FDA approval, this would probably get easier over time, as more studies show effectiveness. [1] https://www.aafp.org/afp/2003/0801/p498.html https://www.aafp.org/afp/2003/0801/p498.html [2] https://www.ketaminewellnesscenters.com/getting-insurance-to-pay-for-ketamine/ https://www.ketaminewellnesscenters.com/getting-insurance-to...
- jokowueu 8y agoNo . It does not have the same anti depressant effects as racemic ketamine .
- mikekchar 8y ago> Suddenly I appreciate my Canadian single payer health care system a lot more, even with the small problems it has. It's been a long time since I lived in Canada, but one of the "small problems" was that prescription medicine wasn't covered. You need private health insurance, or you need to be covered by one of many confusing provincial health care plans. Generally, you can find a way, but at least 15 years ago (when I left) it could be pretty dicey. I remember several of my friends having difficulty affording their insulin when I was in university -- too rich to qualify for aide, too poor to be able to pay for their life saving drugs without hardship. My dad (who still lives there) tells me things have improved, but he still pays more for prescription drugs than I do (living in Japan) I think. The UK's NHS seems to be a better system to compare to ;-) I lived there for 2 years and was really surprised at what the NHS covers. Interestingly they will even pay for emergency treatment for non-residents who happen to be in the country!
- cheerlessbog 8y agoAs well as emergency care being free for non residents, contraceptives and STI treatment are too [1] [1] https://www.nhs.uk/using-the-nhs/nhs-services/visiting-or-moving-to-england/visitors-from-outside-the-european-economic-area-eea/ https://www.nhs.uk/using-the-nhs/nhs-services/visiting-or-mo...
- jdietrich 8y ago>The UK's NHS seems to be a better system to compare to ;-) I lived there for 2 years and was really surprised at what the NHS covers. The caveat is all of the stuff that the NHS won't cover. The service is largely free at the point of use, but there has always been some element of rationing which has drastically increased in recent years due to Conservative government cuts. Mental health gets the short end of the stick in this respect - it represents 23% of the disease burden but only 13% of NHS spending. Most patients with a mental health condition will never see a psychiatrist and receive no more than six half-hour sessions of psychotherapy. If esketamine does prove to be effective, the NHS is exceedingly unlikely to offer it to more than a handful of patients until the patent expires. https://www.nuffieldtrust.org.uk/resource/rationing-in-the-nhs https://www.nuffieldtrust.org.uk/resource/rationing-in-the-n...
- bpchaps 8y agoInterestingly, at least in the US, a take-home prescription for ketamine is already suprisingly cheap - $38 USD for 100ml: https://www.drugs.com/price-guide/ketamine https://www.drugs.com/price-guide/ketamine At least near me, there are "ketamine centers" that already to ketamine clinics - $500 per session, and insurance doesn't cover it. Ends up being around $3000. I haven't done it, so I can't comment on its effectiveness. It's pretty lame that the cost difference is so large. I guess the barrier is a psychiatrist's willingness to prescribe. Maybe all of this research will open up psychiatrists to prescribe take-home ketamine more readily?
- jokowueu 8y agoBasically most clinics will give u a month supply after 6 sessions for 80$ a month
- _acme 8y agoNo, they won't, because the only form available is the IV form. There are no ketamine pills or tablets. Some doctors will prescribe ketamine nasal spray or lozenges to be made by a compounding pharmacy, but the vast percentage of doctors who are willing to administer ketamine in their offices are not at all willing to prescribe a take home dose, and if they are, it's in a very different form with different effects than the IV session. I get regular IV sessions and have compounded lozenges that I take daily, and in my experience neither the nasal spray (which I hated) nor the lozenges are anything like the infusion, and it was extraordinarily difficult to find a doctor in the Boston area that would write any kind of take home prescription. No clinic anywhere is going to give you a bottle of ketamine and some syringes, and neither is CVS.
- jokowueu 8y agoThat's what I meant by maintenance dose . A nasal spray or lozenge. The maintenance doses are great for the vast majority but if you feel that they don't do it for you and able to get a nasal formulation you can do your own IM injection which I know a few people personally that do it once a month
- Pristina 8y ago>single payer health care system is just a system that forces healthy people to pay for unhealthy people.
- iamben 8y agoOr, you know, themselves when they get unexpectedly ill.
- danmaz74 8y agoYes, just like we're forced to pay for police even if we've never been robbed...
- Broken_Hippo 8y agoThis is what insurance and health care does, though. Do you think your premiums are really based on how healthy you are currently? Especially when you have insurance through your employer? In this last case, you might pay more for certain markers (smoking, uncontrolled high blood pressure, and other wellness marks), but not if you have asthma or migraines, for example. Part of your premium is literally paying for folks that are sick. Paying for other people's pregnancies and children and stuff like that.
- empath75 8y agoThat’s literally what insurance is.
- fucking_tragedy 8y agoIf you truly care about costs, and not punishing the sick, single-payer systems are cheaper than private insurance by an average factor of 3[1]. [1] https://en.wikipedia.org/wiki/List_of_countries_by_total_health_expenditure_per_capita#/media/File:OECD_health_expenditure_per_capita_by_country.svg https://en.wikipedia.org/wiki/List_of_countries_by_total_hea...
- empath75 8y agoI don’t know if it’s changed recently, but back when I was clubbing, street ketamine was mostly just stolen from vets offices and dried into a powder.
- pietrovismara 8y agoI wouldn't call it a risk but rather a benefit, in which it makes impossible to not see the absurdity of prohibition laws.
- unparagoned 8y agoThat is exactly why there is a massive h eppidemic in the us. Drug companies lied about oxys , everyone got hooked, couldn't afford it and moved onto h. Now that's laced with fent and everyone is dying
- randomacct3847 8y agoInteresting that there doesn’t seem to be a therapy component to the treatment...meaning you’re just going to a clinic to sort of watch over you as you take it. The price of $3k for 8 doses is so high compared to regular ketamine. I wonder if there is any real difference or if you’re really just paying for the comfort of doing it legally under the guidance of a doctor.
- aaavl2821 8y agofrom what i understand when people go to ketamine clinics it can cost $500+ per infusion. the drug itself isnt that expensive but you have to pay for a doc to supervise you for a few hours some people are studying ketamine + some sort of therapy, but it isnt clear whether this actually works, who it may work for or what the ideal regimen is. the idea is that ketamine treatment provides a very rapid antidepressive effect, but that effect isnt durable after treatment stops. some forms of psychotherapy are more effective when people are only mildly depressed, so ketamine can "prime" people for psychotherapy
- mirimir 8y agoYou're paying for their patent on the delivery system ;) Edit: It's a common delusion that pharmaceuticals are sold for therapeutic uses. Actually, they're a mechanism to monetize intellectual property. Edit: Oops. For having just the active isomer. Edit: That comment about monetizing intellectual property comes from an expert economist :)
- randomacct3847 8y agoActually I just read that Esketamine is patented while Ketamine is not, even though it’s essentially the same thing. So JNJ can charge these ridiculous prices because they changed one small thing about the drug so they could slapped a patent on it.
- mirimir 8y agoThanks. So the next version will be monetizing the delivery system.
- gurumeditations 8y agoAny idea when this will actually be available for patients?
- brisance 8y agoA whistleblower has pointed out that Janssen is “the same company where 31 children died while taking Risperdal, another 1,207 were permanently injured & 14-year-old boys grew breasts, is bringing a ketamine-like nasal spray for depression to market.“ https://twitter.com/melaynalokosky/status/1103114497084940289 https://twitter.com/melaynalokosky/status/110311449708494028...
- apsec112 8y ago"The same company where 31 children died" is incredibly misleading. 31 children died while taking a drug they made, over 15 years, not all of which are necessarily the drug's fault (side effect reporting is very broad). Tylenol kills around 500 people a year, but we don't blame this on the Tylenol manufacturers.
- rubyn00bie 8y agoUmm to be fair, scale should be accounted for, acetaminophen is probably used hundreds of millions times a year. How many times was that drug used when the 31 people died? A million? Not bad. 32? Not good.
- darawk 8y agoKetamine has been used for a long time in veterinary medicine. Its safety profile is super well understood.
- c3534l 8y agoIt's used in human medicine, too.
- _Schizotypy 8y agoI could have sworn it transitioned from human medicine to vet medicine when we found other anesthetics for humans
- 8y ago
- mirimir 8y agoFYI https://www.drugs.com/history/spravato.html https://www.drugs.com/history/spravato.html https://www.drugs.com/alpha/sp.html https://www.drugs.com/alpha/sp.html [not listed yet]
- AnIdiotOnTheNet 8y agoHaving been through chronic suicidal depression, the idea that we're now going to be treating it with yet another psychoactive medication, this time way more powerful and costing significantly more money, doesn't sit right.
- loeg 8y agoIt's just one more option on the market; theoretically supported as safe and effective by scientific evidence. If you have some personal grudge with the chemical, you're free to tell your doctor you don't want to try it.
- RyanUnited 8y agoYup, "science" gave us pharmaceutical Heroin, MDMA, Xanax, Fentanyl, Valium, Vicodin, Methamphetamine, Rohypnol (date rape drug), ketamine (also rapey), phencyclidine (PCP); just to name a few of the many "scientific" ways of addressing depression, anxiety, lethargy and pain. But, as long as we can tell our doctor's we don't want it...
- AnIdiotOnTheNet 8y agoIt is my experience that if you tell a doctor they can't just throw a drug at a problem they get very upset.
- RankingMember 8y agoIf you said it that way with a hostile inflection, maybe, but why wouldn't you just say "I want to try [therapy/a non-drug alternative] first."? If your doctor would react negatively to that, it might be time to find a new doctor.
- AnIdiotOnTheNet 8y agoHere's the thing, the doctor is supposedly the expert, so why am I the one recommending a course of treatment? If I were confident in my own diagnosis and treatment, why do I need the doctor? They're just useless red tape at that point. I explain the reasons I don't want to do the drugs again, and I just get arguments. Because this is the US we're talking about, I've had to change doctors pretty frequently in my life and there are only a small handful I would say wouldn't react negatively. I'm pretty sure the proliferation of Epic has made it worse too.
- pmarreck 8y agoI know a guy who suicided after getting REALLY into ketamine. Color me doubtful.
- ebg13 8y agoI know a guy who suicided after getting really into fishing, so now I'm skeptical of fishing. That's how science works, right?
- pmarreck 8y agoEveryone who responded wins the Internet for pointing out my obvious anecdotal fallacy.
- swiley 8y agoI know a guy who suicided after getting an engineering degree. Stay away from calculus, kids.
- _Schizotypy 8y agoCalculus makes me depressed. Wonder if ket could help
- RankingMember 8y agoI know a guy who breathed oxygen everyday and he suicided. Be safe and hold your breath everyone.
- pmarreck 8y agoProbably my favorite response to my mostly-intended obvious anecdotal fallacy. He was a really good/unique/smart guy, though :/ He was also pretty staunchly atheist... Perhaps he needed to know, once and for all.
- biglenny 8y agoSerious question: is this what Lil' Pump's ESKETIIIIIT is?
- epmaybe 8y agoI posted on the original story about the FDA panel recommending approval a few weeks ago. In that post, I mentioned that Icahn school of medicine holds the patent on the racemic ketamine (instead of S-ketamine) intranasal formulation for treatment of depression. I heard about the approval on NPR, where they interviewed a doctor from Icahn school of medicine to talk about the benefits of such a formulation, without any mention of this patent. Is there any way to find out if J&J licensed their patent? Edit: meant racemic instead of non racemic
- jboogie77 8y agoI listened to it on NPR as well and they did mention the patent
- gojomo 8y agoFTA: F.D.A. approval requires that doses be taken in a doctor’s office or clinic, with patients monitored for at least two hours… The safety monitoring will require doctors to find space for treated patients, which could present a logistical challenge, some psychiatrists said. I can kill a few birds with one stone here. Doctors should offer the 2-hour sessions in the evening, in darkened "clinics" with dance floors and DJ music.
- empath75 8y agoBasically every drug that ravers were doing is turning into a breakthrough treatment for various psychological disorders.
- Cynddl 8y agoThe original title is "Fast-Acting Depression Drug, Newly Approved, Could Help Millions". Not everyone reading HN lives in the US nor knows what the FDA stands for. The article reports the experiment, the results, and not only FDA approval.
- rygxqpbsngav 8y agoWhy do people get depressed? Break up, lost loved ones, lose a job etc. etc. Why don't they prescribe these people to have some voluntary work at a local charity and take a break from life's stress and enjoy the joy of giving? etc. r understand or fix the reason they got depressed in the first place? Or simply some consoling or support. Why does everything need a chemical cure that messes up the brains natural balance and harmony? When you give and bond with people, your body releases oxytocin. When you do cold showers, your body releases seretonin. When you laugh or meditate, your body releases endorphin. I can go on and on. All of which helps bring back balance to the mood and get people rid of depression. You create a chemical/toxic & selfish society,where everything MUST be fixed through chemical drugs backed by greed of pharma companies that does half-dashed studies, you are doing humanity endless harm.
- cr1895 8y ago>Why do people get depressed? Break up, lost loved ones, lose a job etc. etc. This is not depression.
- ketamineuser 8y agoI'm really happy to see this finally happening. I've used ketamine in a homemade emergency nasal spray in times when I have been extremely depressed, and I do believe it has saved my life. My DIY nasal spray is made from liquid ketamine vials purchased off the dark net. The vials are 1g in 10ml saline and are intended for veterinary use. They come factory sealed with holographic labeling, and I'm confident they are legit. They cost $100-$150 each which is a lot more than powder but I am much more confident in what I'm getting and it's already in liquid form. I use a needle to extract the ketamine from the vial and put it into an amber glass nasal spray bottle after sterilizing it. The solution is already isotonic, no need to add any salt. I'll do a squirt on each side of my nose against the nasal wall when I'm really depressed / suicidal, which is usually no more than once a month. It's not magic, but it really brings me back to reality about half the time. I have also tried an IV ketamine clinic, paid about $3k to go 3 times. Unfortunately that is super expensive and the last time I had what amounted to a bad trip and I haven't been back. If anyone has any questions about these I'm happy to answer them. To anyone feeling depressed: If you haven't done so already, get the basics out of the way: Get a physical and get your thyroid levels checked. Consider supplementing vitamin D, fish oil, and magnesium. You can find academic evidence that those may help in people who are deficient.
- GuillaumeBrdet 8y agoSeems interesting, I need to take the time to look further into this one. Hopefully, it will help some people.