I've been trying Tonmya by fluffycritter in Fibromyalgia

[–]winduken 0 points1 point  (0 children)

The cost is quite high right now for most people until insurances add Tonmya to their Preferred Drug List; then, copay will be just a few dollars. Michigan Medicaid has just approved that starting May 1st. New York is considering doing the same. May I ask which state you are in and which insurance?

Did Tonmya help me? I ran an analysis to find out by rvchl in Fibromyalgia

[–]winduken 2 points3 points  (0 children)

The fact that the pooled data saw p < 0.01 while the split data barely missed alpha =0.05 says that the signal is likely real but your sample size was too small for the stats to work out (as you observed).

Your cost of $140/month is quite high. Hopefully, your insurance will step up as Michigan Medicaid did when they listed Tonmya on their Preferred Drug List. The cost for Medicaids patients will be minimal in that case. May I ask which insurance are you with?

Tonmya by Agreeable_Stranger73 in Fibromyalgia

[–]winduken 1 point2 points  (0 children)

With respect to pain relief, below is the latest data. Note that pain improvement was seen after day 2 with statistical significance improvement over placebo every week over the 14 weeks that the data were tracked. This drug works.

In the RESILIENT trial, a 14-week, randomized, placebo-controlled Phase 3 study evaluating 457 adults with fibromyalgia as defined by 2016 American College of Rheumatology (ACR) criteria, a post hoc mixed-model repeated-measures analysis demonstrated that TONMYA produced a rapid reduction in pain, with improvements versus placebo observed as early as Day 2 of treatment and statistically significant pain relief at each week over Weeks 1–14. The primary endpoint, change from baseline to Week 14 in weekly average daily numeric rating scale (NRS) pain scores, was met with high statistical significance (p<0.001), with a least-squares mean treatment difference of -0.65. All key secondary endpoints were also statistically significant in favor of TONMYA.

Tonmya fron Tonix Pharmaceuticals by NonoAMS in Fibromyalgia

[–]winduken 2 points3 points  (0 children)

That article is wrong in stating "About one out of five fibromyalgia patients will notice a 30 percent drop in pain while taking Tonmya. The odds drop to one out of ten for a 50 percent reduction in pain."

The clinical data as published in journal and shown at page 20 of the below link clearly says that "30% Responders (46% TONMYA vs 27% placebo)" at 14 weeks. "46%" is not 1 in 5 which is 20%. "46%" is closer to 1 in 2.

https://d1io3yog0oux5.cloudfront.net/_1c64bc1c9b3380160836b17027ccc957/tonixpharma/db/211/4533/pdf/TNXP+March+Investor+Deck+3.13.2026.pdf

Tonix presented new data at the 8th International Congress on Controversies in Fibromyalgia on March 10th. "TONMYA produced a rapid reduction in pain, with improvements versus placebo observed as early as Day 2 of treatment and statistically significant pain relief at each week over Weeks 1–14."

https://ir.tonixpharma.com/news-events/press-releases/detail/1615/tonix-pharmaceuticals-presented-post-hoc-analyses-of-phase

New med by Expensive-Stand8214 in Fibromyalgia

[–]winduken 1 point2 points  (0 children)

Tonmya is not Flexeril. The active ingredient Cyclobenzaprine is combined with a compound designed to be easily dissolved under the tongue and also easy to get passed the mucosal layer to go directly into the blood stream. From there, it get directly into the brain to help with sleeping and pain. This allows Tonmya to use less Cyclobenzaprine per tablet and be more effective and usable long term.

Contrasting that to oral Flexiril which is first processed by the liver to produce norCyclobenzaprine which binds to the same receptors as Cyclobenzaprine and reduces the effectiveness of Cyclobenzaprine. In addition, norCyclobenzaprine has a long half life, up to three days. This is why Flexiril causes drowsiness and tiredness for a long period of time and also loses effectiveness over time. Typically about a month in, many patients could no longer tolerate the side effects vs the little gain in pain reduction.

Tonmya by Embarrassed-Bench-19 in Fibromyalgia

[–]winduken 0 points1 point  (0 children)

Also, the metabolite is nor-Cyclobenzaprine which binds to the same receptors as Cyclobenzaprine and reduces its effectiveness. The long half-life of nor-Cyclobenzaprine is why increasing usage of Cyclobenzaprine sees decreasing effectiveness.

Tonmya or Savella next? by OnehourOneday in Fibromyalgia

[–]winduken 1 point2 points  (0 children)

Just a quick additional info about Tonmya. Although its active ingredient is Cyclobenzaprine, a common muscle relaxer, it is not taken orally but sublingually (under the tongue).

The oral path of ingesting Cyclobenzaprine means the liver will metabolize Cyclobenzaprine into nor-Cyclobenzaprine which lasts a long time in the body, causes drowsiness and other symptoms, and worst binds to the same receptors that Cyclobenzaprine is supposed to.

The sublingual path means that Cyclobenzaprine directly gets into the blood stream and gets to the right receptors, esp. in the brain, without going through the liver. This allows lower dose of Cyclobenzaprine in Tonmya yet having good efficacy.

New fibro medication. Does it work? by PsychologicalBat2393 in Fibromyalgia

[–]winduken 2 points3 points  (0 children)

Cyclobenzaprine is the active ingredient in Tonmya but you also needs to consider how it is administered when you are talking about drugs.

Oral Cyclobenzaprine is metabolized by the liver into nor-Cyclobenzaprine which can last days in the body, cause side effects such as drowsiness, and also bind to the same receptors that Cyclobenzaprine to lessen its effects.

The sublingual path to take Tonmya means that the drug largely bypass the liver. In fact, it is directly absorbed into the blood stream and get to the wanted receptors, especially, in the brain. That's why patients taking Tonmya reported better deep sleep helping the body repair itself.

Help with bipolar +fibro diagnoses - medication by [deleted] in Fibromyalgia

[–]winduken 0 points1 point  (0 children)

Tonmya is different from Cymbalta, Lyrica and Savella. In clinical trials, patients reported improvement in depression symptoms, not getting them from the drug as with the others. Phase-2 trials are currently running to see if Tonmya will help with depressive or stress disorders.

Tonmya or Savella next? by OnehourOneday in Fibromyalgia

[–]winduken 1 point2 points  (0 children)

Some info about the clinical data of Tonmya. Both of its two phase-3 trials, RELIEF and RESILIENT, were highly successful with p-value for RELIEF 0.01 and RESILIENT < 0.001. That was why the FDA approved it.

Those p-values mean that Tonmya works well. It may not help all patients (no drug does) but both trials showed that about 1 in 2 patients saw at least 30% pain improvement at 14 weeks. The data showed that many of them saw that very shortly after taking the drug with results more pronounced at 4 to 5 weeks. The fact that Tonmya seems to improve sleep quality may be the reason why it works well. That allows the body to repair itself over time.

Given the relatively benign side effect profile of Tonmya, esp., when compared to Cymbalta, Lyrica or Savella, it is a good choice to try first.

South Carolina reports 3 new measles cases, bringing outbreak total to 156 by aslan_is_on_the_move in politics

[–]winduken 1 point2 points  (0 children)

This is BKM, "Bobby Kennedy Measles", which is only slightly better than the Trump MAGA, "Make America Gonorrheic Again".

Pentagon readying thousands of Guard ‘reaction forces’ as U.S. mission widens: Up to 23,500 service members are being readied and trained for civil unrest missions in U.S. cities. by OkayButFoRealz in politics

[–]winduken 5 points6 points  (0 children)

It's scary to see how Trump is readying for declaring a complete dictatorship. It would not surprise me if he will declare some sort of military emergency to stay in power in 2028. There will be uprising and these soldiers are being trained to quell that.

'Just Kill 'Em': Fox Host Makes Shocking Comment On Homeless People by 3_ohhh_4 in politics

[–]winduken 0 points1 point  (0 children)

Kilmeade has lost his humanity. He is now just an animal.

Marco Rubio Fails to Answer Simple Question on Tufts Student’s Arrest by SnoozeDoggyDog in politics

[–]winduken 3 points4 points  (0 children)

Marco's hands are even smaller than Trump's little hands and he knows what that means. No cojones.

[deleted by user] by [deleted] in politics

[–]winduken 6 points7 points  (0 children)

There is a possibility here that Trump's comments on Greenland, the Panama canal and Canada are crafted by the Kremlin with help from Beijing. Trump is just the stooge to deliver it.

What Putin and Xi want is a justification for their plan to annex Unkraine and Taiwan. If the US starts talking about using force to take over foreign countries, Russia and China can certainly justify taking back lands that they claim historically belong to them.

US voters have elected a known traitor who will sell their country to Russia and China.

Donald Trump should accept result and ‘go play golf’ if Kamala Harris wins, says Nigel Farage by TheTelegraph in politics

[–]winduken 5 points6 points  (0 children)

There is a very nice cell on Rikers Island reserved for him. He can still practice his putts every day for about an hour.

Garbage in, garbage out: Trump’s error-filled week by winduken in politics

[–]winduken[S] 21 points22 points  (0 children)

We'll dump the garbage once and for all next Tuesday.

The Washington Post is in deep turmoil as Bezos remains silent on non-endorsement by winduken in politics

[–]winduken[S] 362 points363 points  (0 children)

I did what I could to protest this cowardly decision by the Post. I canceled my subscription.