I am starting a new discussion about Suzetrigine a novel drug for pain

Posted by kdks99 @kdks99, 5 days ago

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.

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cheryl333 | @cheryl333 | 5 days ago

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!

kdks99 | @kdks99 | 5 days ago

Here is a link (there are many more) you can share with your doctor, if needed. https://en.wikipedia.org/wiki/Suzetrigine

pklouky | @pklouky | 3 days ago

Interesting. Hope it gets approved.

bayhorse | @bayhorse | 2 days ago

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?

kdks99 | @kdks99 | 2 days ago

The phase 2 trial for lumbar radiculopathy was inconclusive due to poor study design. Vertex is hoping to move on to a phase 3 trial with a better study design.
As of now I believe it will get FDA approval for acute pain, perhaps as early as thursday.
I have read all the research and I believe it will be effective for chronic pain but that is just my opinion. There’s lots online so you can check it out. I hope to get it off label for my chronic pain as soon as it’s approved.

jthomas458 | @jthomas458 | 1 day ago

In reply to @pklouky "Interesting. Hope it gets approved." + (show)

For sure. Everything I’ve read says by the end of this month. Only a couple of days left 😉

kdks99 | @kdks99 | 1 day ago

In reply to @jthomas458 "For sure. Everything I’ve read says by the end of this month. Only a couple of..." + (show)

I am not sure the FDA will be able to inform the public of their finding, so I think the Vertex site will release the information....at least if it's approved.

John, Volunteer Mentor | @johnbishop | 1 day ago

Here are some references on the drug...

-- Pharmacology and Mechanism of Action of Suzetrigine, a Potent and Selective NaV1.8 Pain Signal Inhibitor for the Treatment of Moderate to Severe Pain: https://link.springer.com/article/10.1007/s40122-024-00697-0
-- Fresh from the biotech pipeline: FDA approvals settle in 2024, but what next?:
https://www.nature.com/articles/s41587-025-02555-6
-- Global first-in-class drugs approved in 2023-2024: Breakthroughs and insights:
https://www.cell.com/the-innovation/fulltext/S2666-6758(25)00004-9

jthomas458 | @jthomas458 | 20 hours ago

https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class
Now, it will be interesting to see how quick doctors are to prescribe it, if pharmacies can fill the prescriptions and how much it will cost. I don’t expect insurance will cover it right away.

"Vertex has established a wholesale acquisition cost for JOURNAVX in the United States of $15.50 per 50mg pill.”

kdks99 | @kdks99 | 9 hours ago

Thank you! you're amazing... I couldn't find this. I don't know your situation but if you have medicare it's my understanding that medicare must cover it based on this new legislation. (Please post anything more you can find out in this thread) I plan on finding a doctor who will prescribe it off label and then battle it out with medicare is necessary. https://avanos.com/pain-management-and-recovery/nopain-act.