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Suzetrigine - a novel drug for pain
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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I’m not sure if by “off label” you mean generic or something else. I do know that most new drugs are developed under patent protection.
From google search: “Most brand drugs are developed under patent protection for up to 20 years. This means that no one else is allowed to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug.“
I don’t want to be the bearer of bad news, but I do want all of us who suffer from chronic pain to be as informed as possible.
Hugs to all of my fellow warriors.
Just asked my PCP about it two weeks ago. Never heard of it.
Asked my orthopedic surgeon and he said he wrote one script to someone that had a previous prescription from her previous home town. Ask my spinal pain interventionist and he said he won’t waste his time as of now because it’s to expensive, the company wants a letter from the Dr. as to why he is prescribing it as they might help out with the cost but his research indicates they usually decline it.
Also, not approved for chronic pain, only acute as in post op pain. Long story short,
America, best healthcare in the world if you’re wealthy.
The problem with Journvx is that it is only for acute pain, so those of us with Long term pain are out of luck....at least for now. That is my understanding.
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3 Reactions"Off label" generally refers to use of a drug to treat a condition for which it has not been approved by the FDA. IIRC years ago the was a BP med called Clonidine that was said to be useful in helping folks stop smoking. A physician could prescribe it for that use even tho it wasn't approved for that use.
I had growths on both adrenal glands that were producing cortisol. Last August I had one adrenal gland and its growth removed and I'm still producing too much cortisol. I'm currently involed in a reserach trial at Mayo with a drug that may help regulate cortisol levels. It is currently used to help diagnose adrenal insuffiency or not producing enough cortisol. I'm not too keen on giving up my other adrenal gland and living on meds the rest of my days.
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3 ReactionsThanks for your reply, I appreciate the information. I truly hope that the study yields great results and that you’ll be able to keep your gland. 🥰