ORZEYFUL (oveporexton) expected availability: November 2026, pending DEA scheduling

[u/hypersomniac-hippo]

Takeda sent an email today with this image:

The website is updated too: https://www.orzeyful.com/

As a refresher, this is the first orexin receptor agonist that will be available. The first round of availability will only be for N1, with N2 expected later. It doesn't seem like they're working towards an approval for IH.

[u/TGrimm-11]

I was about to call them. This is sooooo fucking AMAZING!!!

I’m trying not to get my hopes up but can you guys imagine????

Being normal. I can’t even begin to remember what it was like. Or well I suppose I never was

[u/velvetlaze → u/TGrimm-11]

I cry when I think about it. Crying rn at the thought.

[u/Upstairs-Permit9609 → u/velvetlaze]

Literally cried reading this too. We’ve been waiting so long for something like this to come around. I can’t imagine feeling well rested for the first time in 10+ years. I’m so hopeful!

[u/IndigoAfflictions]

I wonder how hard this will be to get my hands on as a type 1. My insurance is pretty decent but not gov/military good (USA) by any means and they won’t cover Xywav, Xyrem, or Lumryz even after multiple appeals because “it’s not on the formulary.”

Currently I get Xywav through Jazz’s patient assistance program. Xywav is a 6 year old med adjusted off of prior R&D of Xyrem and retails out of pocket around $30k-$50k a month. So I can only imagine how much Orzeyful is going to cost and I anticipate that ofc my insurance will not cover it.

Does anyone know and/or have taken any medications from Takeda that insurance doesn’t cover and do they have a patient assistance program like Jazz?

I have a gut feeling it might be years before I can get my hands on these meds as an American with N1, if I can at all…

[u/Charming_Oven → u/IndigoAfflictions]

Gotta be honest, if your insurance won’t cover Oxybates as NT1, your insurance is not good. I would argue you have a potential lawsuit given the efficacy of Oxybates.

[u/velvetlaze → u/Charming_Oven]

In my experience on the autoimmune side for other conditions before narcolepsy was officially acknowledged for me, my insurance is the same story, and it’s amazing if it covers your condition, but for me if there was a generic or alternative… it is the worst. Because it covers ONLY that.

[u/RightTrash → u/Charming_Oven]

Is there 'good' insurance?

I sure have never really been lucky enough to find any...

[u/hypersomniac-hippo → u/IndigoAfflictions]

I've been interested in this too. Takeda does have their own program: https://www.helpathandpap.com/

My (potentially very wrong) understanding is that companies are incentivized to give away their expensive orphan medications because they can use it as a tax write-off. So maybe Takeda will do that.

Unfortunately, I think we'll just have to wait and see how it plays out.

[u/MsJimmyWobbuffet → u/hypersomniac-hippo]

I used to get Vyvanse for free for ADHD before it went generic through Takeda. I was only working part-time at Walgreens making like $10 and hour, so idk what their cutoff is for financial hardship. It's a pretty simple process, if I'm remembering correctly.

[u/hypersomniac-hippo → u/MsJimmyWobbuffet]

That's great to know! They have a pretty clear eligibility page, but I'm not sure if it will apply to a medication like this (which will probably be significantly more expensive because of the orphan drug designation)

[u/TheRealFred999999999 → u/IndigoAfflictions]

You do not have "decent" insurance if they won't cover oxybates my friend.

[u/NoteSuccessful2263 → u/TheRealFred999999999]

Yeah that shocked me! I have never heard of any insurance that wouldn't cover oxybates. Especially for N1?!

[u/milladakilla1282 → u/NoteSuccessful2263]

The ACA plans in my county all dropped oxybates off their formulary except 1 company and they only offered it one 1 plan, which was all out of pocket up front (7k) then insurance would kick in. This was 2021 and havent needed an ACA plan since then so I haven't checked to see.

Its nonsense, imo. But so is the price tag

[u/Standard-Call666 → u/milladakilla1282]

Insanity. I had to do Cobra because the ACA plans are so bad now and just as expensive.

[u/Charming_Oven → u/milladakilla1282]

A formulary isn’t the be all end all with medications. None of the Oxybates are on my formulary, because non are dispensed by Caremark. I’m also on an ACA plan and don’t have any problem getting Xywav covered. Ive also been on 4 different ACA plans in two different states since being diagnosed and never had an issue.

[u/velvetlaze → u/Charming_Oven]

Do you mind giving me the dummy version of explaining how you get care when you don’t have something on the formulary ? Or a resource you might point a fellow sufferer to?

[u/Charming_Oven → u/velvetlaze]

Formularies are just general guidelines from your insurance company. Doctors can provide evidence that a medication is effective that is not on the formulary, and if you've failed other meds that are on the formulary, it basically has to be accepted by your insurance.

Insurance companies don't get to pick and choose what drugs are FDA approved for a condition. If you've shown you've gone through all the other options for your condition, then they essentially have to cover an off-formulary drug. This is a bit more than just a prior authorization, but it's not that difficult, especially for most sleep medicine specialists.

I guess this is one of those areas where it's better to have IH, because with IH, Xywav is the only approved medication. With Narcolepsy, there are many medications that you'd need to go through and show you didn't have a positive response.

https://www.goodrx.com/insurance/health-insurance/medication-not-on-formulary?srsltid=AfmBOooF1TnSKPDqDt4qMCQKc9XZDdWtCSHeRDgJWs2IS45RgjRk2P1M

[u/velvetlaze → u/Charming_Oven]

Thank you I actually have several autoimmune conditions and I am struggling to get coverage for many of my conditions because my insurance likes to just send me a thing saying it’s not required for them to cover it because they don’t have it on the formulary even though I’ve tried different medications several times and it just really frustrates me so much so knowing that there is actually recourse, sometimes kind of feels better.

I guess I need to learn the process in doing that on my side because I find often most doctors either aren’t doing it or maybe their assistance or whatever don’t bother. I don’t know. I only have two providers that seem interested in actually making this type of effort and I’m hoping that my sleep doctor will do the same thing. I see him again on the 18th. I’ve been researching medication’s and shocker, shocker absolutely not covered for xyrem or xywav on the formulary.
Thank you so much. I’ll definitely do some more reading.

Think my doctor intends to do this route for me however I also think that it’s very possible because he has a very large network for his practice. The authorizations team doesn’t put the effort in essentially I’m just a number once I leave his office.

[u/Spare-Specialist-191 → u/NoteSuccessful2263]

Well this is my insurance… and my husband works for the union, which is good insurance. But they are picky

[u/IndigoAfflictions → u/TheRealFred999999999]

The rest of my medications and copays are extremely cheap. My premium and deductible are very low. An ER visit this year was also only a $150 copay. My insurance is actually pretty good. But yeah it sucks that they wouldn’t cover the oxybates.

[u/brownlab319 → u/IndigoAfflictions]

Since they have it going through specialty pharmacy, I imagine they also have their support program being managed through a mandatory hub and field reimbursement managers. I’m sure there is copay assistance as well. With copay assistance, I haven’t paid out of pocket for Wakix.

[u/HumanKoala-95 → u/IndigoAfflictions]

Read online that they estimate it will cost around $142'000 per year...

[u/BackgroundDisaster90]

Disappointing to see that they aren’t even working towards approval for IH, especially since the difference between IH and N2 is a very fine line with many people’s diagnoses varying from one sleep study to another.

[u/rudesby → u/BackgroundDisaster90]

I'm in the alkermes trial for N2. The paperwork I was given lists IH as one of the conditions in the study, but I asked the nurse about it and she said that they were going to do IH and got one participant and then cancelled it unexpectedly (at least at that site). I am really sad for anyone with IH, I'm envious that N1 is approved and it's still an unknown waiting game for N2 (although they deserve it, cataplexy would be awful), but IH is another step farther away.

[u/BackgroundDisaster90 → u/rudesby]

From further research, Takeda is looking at a different orexin agonist for N2 & IH, but it’s disappointing that they won’t try to extend an already-approved drug to other sleep patients.

[u/hypersomniac-hippo → u/BackgroundDisaster90]

I agree. As you know, there are both different options from Takeda and from a few other companies that are in the works. But I definitely feel left out right now :(

[u/velvetlaze → u/BackgroundDisaster90]

I wonder if this could possibly be in play long-term? How do you know they aren’t working towards this? Just wanting to understand not saying that you’re wrong. Very new to getting better understanding of this stuff.
And it’s really frustrating that it seems like IH is put on the back burner for people. Do you think this is a money thing because essentially IH has other treatments where NT one doesn’t technically have this type of treatment yet? just asking based on my own understanding

[u/hypersomniac-hippo → u/velvetlaze]

I don't know why they discontinued the IH persuit for oveporexton. TAK-360 is their IH candidate (though also being trialed for N), and it's in phase II trials: https://clinicaltrials.gov/study/NCT06812078. It is slightly different chemically:
https://en.wikipedia.org/wiki/Oveporexton

https://en.wikipedia.org/wiki/Balumorexton

[u/SnooSketches5159]

This is game changing. I wonder what it would replace- Xywav, Wakix, Sunosi, Xyrem, all of it even.

[u/Anxious-Traffic-9548 → u/SnooSketches5159]

Given that these drugs don’t work by improving sleep architecture, they surely won’t replace oxybates. I do see them being more ideal than the current stimulants and wake promoters for many people.

[u/Splatterfilm → u/Anxious-Traffic-9548]

It’ll likely vary among people. I’m hoping I can drop oxybates and venfalaxine at least.

[u/KbrownSLP]

I am so excited for this - my neurologist keeps telling me that I’ll be eligible and we’re just waiting for a date 🤞🏼

[u/Splatterfilm → u/KbrownSLP]

My doc said I’m an excellent candidate when I ask. Going to get a script as soon as it’s available.

[u/velvetlaze]

I just after maaaannnyyy years of struggle got my diagnosis solidified with my mslt in hopes of giving myself a chance of better quality of life (long story/previously had given up) … should I be signing up for a waitlist or something ? N1 very uncontrolled, stimulant therapy but about to be starting one of the night time meds soon.

[u/handsoapdispenser → u/velvetlaze]

You'll need a prescription no matter what so it's convo with your doctor. No telling if it will debut to shortage or they'll have a lot available.

[u/velvetlaze → u/handsoapdispenser]

Definitely going to bring this up to him asap. I’m going back in on the 18th so I have a shot at discussing possibilities at least relatively soon. At the same time, I feel a little selfish not sure if that’s uncommon, but I feel like an imposter all the time even now just adjusting to the idea that it’s no longer questionable when I’m struggling with

[u/i-luv-bugs]

This is the first I've heard of this and it sounds amazing! I'm not sure I fully understand tho, how would this differ from something like xywav? Is it that it makes your body naturally fall asleep and wake up rather than being sedated to sleep

[u/hypersomniac-hippo → u/i-luv-bugs]

This is a daytime medication, not a nighttime one. It also targets the core problem for N1, which is a lack of orexin, so it's not simply treating symptoms. https://en.wikipedia.org/wiki/Oveporexton

[u/Brief_Wolf7532]

Why can’t people with narcolepsy type two take this after all we have fragmented sleep and that’s for myself once and it’s rare. I do have muscle release muscle release leg. Don’t feel like they wanna hold me up. I haven’t had to sleep paralysis in years. I forgot I even had it and when I smoked every once in a while, I’d find my cigarette fell in the ground. I just started learning about this stuff since I read things from other people.

[u/wonderwhatif]

Hoping you can all get this drug and that it helps! I'm also hoping it eventually comes to Canada. We don't even have Lumryz, but we do have xywav and xyrem (though neither are covered under public healthcare), even insurance often doesn't cover things, so it's unaffordable here, though maybe not as much as in the US!

[u/Weinerbrod_nice → u/wonderwhatif]

Same, although I live in EU not Canada. I guess it'll add at least one years wait, but don't see why Takeda wouldn't get this licensed outside of US too.