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

Posted by kdks99 @kdks99, Jan 26 11:32am

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.

Like Helpful Hug

Interested in more discussions like this? Go to the Chronic Pain Support Group.

Sounds promising but it will be a new patent so we will pay dearly until it gets a generic version. Am I right?

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@mikaylar

Sounds promising but it will be a new patent so we will pay dearly until it gets a generic version. Am I right?

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Initially, I believe you are correct. In the next fiscal year, Medicare should negotiate a lower price per dose ($15.50) and we can start to see what the insurance carriers really are more frightened of, lawsuits from patients that develop opiate use disorders because they could not obtain Suzetrigine because they were denied coverage, or the cost (maybe $3.00 per 50 mg) of Medicare negotiated pricing.
I have never been at the accounting end of medicine so I have no clue which way it will fall. What I do know is that the high initial pricing will lead to many additional drugs of the Na 1.8 volt class being developed and cleared which will completely change market dynamics - eventually. Hope most of us can wait.

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I saw in my news feed yesterday that the FDA has now approved it. The article said that it is expected to be very helpful for acute pain after surgery (so that doctors don’t have to prescribe opioids) but possible less effective for chronic pain. If I can find the article again I’ll post the link.

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https://apple.news/Aft1cEqH_TtaB2nab3zqS_g
Found it - there were actually 4 news sources, including Time and the BBC. The brand name is Journx.

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@mikaylar

Sounds promising but it will be a new patent so we will pay dearly until it gets a generic version. Am I right?

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I am relatively sure medicare wii have to cover based on the NOPAIN Act (1/25)...if you don't have have medicare it will probably cost an arm and a leg. Here is the bill. It went into effect 1/25. https://www.congress.gov/bill/117th-congress/senate-bill/586/text

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@lwmarcrum

I saw in my news feed yesterday that the FDA has now approved it. The article said that it is expected to be very helpful for acute pain after surgery (so that doctors don’t have to prescribe opioids) but possible less effective for chronic pain. If I can find the article again I’ll post the link.

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Yes the phase 2 trial was inconclusive. It was a very badly designed trial. Vertex is hoping to start a phase 3 trial with a better design. I, based only on my judgement and all the research I I could do, believe it will be successful...again only my best guess. I plan to try it for my chronic pain....yes i'll be a guinea pig...but it will either help or not help. The side effect profile was excellent albeit it was only reported for 3 months.

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The brand name is Journavx (NA refers to the sodium channel blocker aspect, and NAV is the gene that is targeted; X probably means they know it works on the NAV1.7 gene for people who experience genetically caused pain all the time, and are hoping it will work on other NAV1 genes for people with acquired neuropathic pain, such as pinched spinal nerves and diabetes).

IF it works on, say lumbrosacral radiculopathy, and IF Medicare will cover off-label RXs for office visit patients, we would probably have to give up Medicare Part C for Medicare to cover it. So that's something to think about if you take other expensive drugs, or see doctors less expensively with Part C than without.

It sounds like Vertex is going to do a larger Phase III trial. I wonder if they are enrolling patients for the trial yet.

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@tr1

The brand name is Journavx (NA refers to the sodium channel blocker aspect, and NAV is the gene that is targeted; X probably means they know it works on the NAV1.7 gene for people who experience genetically caused pain all the time, and are hoping it will work on other NAV1 genes for people with acquired neuropathic pain, such as pinched spinal nerves and diabetes).

IF it works on, say lumbrosacral radiculopathy, and IF Medicare will cover off-label RXs for office visit patients, we would probably have to give up Medicare Part C for Medicare to cover it. So that's something to think about if you take other expensive drugs, or see doctors less expensively with Part C than without.

It sounds like Vertex is going to do a larger Phase III trial. I wonder if they are enrolling patients for the trial yet.

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I am wondering that too. If you find out could you let me know here or in a private message? I am very interested in participating. Thanks.

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@kdks99

I am wondering that too. If you find out could you let me know here or in a private message? I am very interested in participating. Thanks.

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I do not find any new clinical trials listed yet. But I did find information on who should NOT take this drug, which may be of interest. This is from the Vertex (news dot vrtx dot com) site:

IMPORTANT SAFETY INFORMATION

Patients should not take JOURNAVX if they take certain medicines that are strong inhibitors of an enzyme called CYP3A. Patients should ask their healthcare providers if they are not sure.

Before taking JOURNAVX, patients should tell their healthcare provider about all of their medical conditions, including if they: have liver problems. People with liver problems may have an increased risk of getting side effects from taking JOURNAVX; are pregnant or plan to become pregnant as it is not known if JOURNAVX will harm an unborn baby. Patients and their healthcare providers should decide if they will take JOURNAVX while they are pregnant, are breastfeeding, or are planning to breastfeed, as it is not known if JOURNAVX passes into breast milk. Patients and their healthcare providers should decide if they will take JOURNAVX while they are breastfeeding.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking JOURNAVX with certain other medicines may affect the way JOURNAVX and the other medicines work and may increase patients’ risk of side effects. Patients should ask their healthcare provider or pharmacist for a list of these medicines if they are not sure.

Patients should especially tell their healthcare provider if they take hormonal birth control medicine (contraceptives) containing progestins other than levonorgestrel or norethindrone. If they take one of these contraceptives (progestins other than levonorgestrel or norethindrone), they may not work as well during treatment with JOURNAVX. Patients should also use nonhormonal contraceptives such as condoms or use other forms of hormonal birth control during treatment with JOURNAVX and for 28 days after they stop taking JOURNAVX. Medicines that are substrates of the CYP3A enzyme may become less effective during treatment with JOURNAVX. Their healthcare provider may need to adjust the dose of patients’ medicine when starting or stopping JOURNAVX. Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine. Patients should not take food or drink containing grapefruit while taking JOURNAVX.

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Thanks...none apply to me.except an occasional grapefruit juice, but I can stop. You seem to be a researcher like me so please share whatever you find here....I continue to be interested in a clinical trial.

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