Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

[Dolphin]

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years

Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years Fibromyalgia is a chronic pain condition that affects more...

www.globenewswire.com

 

[Utsikt]

It failed in an LC pain trial:

https://www.s4me.info/threads/tonixs-long-covid-drug-fails-to-meet-midstage-trial-goal.35180/

 

[perchance dreamer]

In the U.S., cyclobenzaprine hydrochloride is commonly known as Flexeril. I wonder if the only difference in Tonix's new drug is that it's sublingual.

 

[Kitty]

Don't know anything about the drug, but I did wonder what proportion of the English speaking world will misread the company name as Toxic Pharmaceuticals.

Then again, maybe normal people with non-ME/CFS brains don't do it so much!

 

[perchance dreamer]

Don't know anything about the drug, but I did wonder what proportion of the English speaking world will misread the company name as Toxic Pharmaceuticals.

That's exactly how I misread it at first glance! It's really not a great name for a pharmaceutical company.

 

[shak8]

Tonix investor conference call audio (recorded from today's broadcast about Tonmya):

https://edge.media-server.com/mmc/p/gsey5g7m

I'll check with clinical trials.gov and see if any publication of trial details exists. It's a sleep architecture agent by increasing Stage 4 or deep sleep, where muscle repair takes place, among other things.

I am not bowled over by a 30% pain reduction as pain in FM is highly variable day to day, hour to hour. My go-to clinical FM doc/researcher postulates that one needs a 60% pain reduction to be clinically meaningful (Dr Daniel Clauw, U-Michigan).

Edited

 

[shak8]

ClinicalTrials.gov

clinicaltrials.gov

I'm not sure how to evaluate the current trial since it is open label, fewer research subjects than ones in two previous trials (which were double-blinded, but this Phase 3 was open label, hmm.)

 

[shak8]

Published trial results from 2023:

https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.25142


2025 published trial results (PDF available):

https://academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf089/8193722

 

[Peter T]

That's exactly how I misread it at first glance! It's really not a great name for a pharmaceutical company.

Each time I see it, even though I now know what it is, I still read Tonix as ‘toxic’ and have to take a second glance.

 

[Yann04]

Good article about Tonmya trial and implications:

https://www.medcentral.com/rheumatology/fibromyalgia/fda-approves-cyclobenzaprine-for-fibromyalgia?ap=nl2367&rhid=VH0209129&mui=&lid=14093996&mkt_tok=NTQxLUdLWi0yNDMAAAGcYbY75BBd_YeicM3XboWHpixw_dQZKDvzk0Qk5K_W9IiDM2lQnHZAO42A-Nib54L5yoSuajbBs-MYyCSrBy_2SOG4sebVvecFfcKZXbWqeOJBaQ

https://www.medcentral.com/rheumatology/fibromyalgia/fda-approves-cyclobenzaprine-for-fibromyalgia

(link without tracker)

 

[Mij]

by Rebecca Handler | Oct 3, 2025 | BHC News, Fibromyalgia, Provider Education, Research News

New Hope in Fibromyalgia Treatment: Understanding Tonmya

 

[voner]

interesting and odd. Just a reformation of Flexeril??

Here’s a link to the companies publication in the journal, “pain medicine”:

https://academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf089/8193722

Here is the graph from the paper of the Primary efficacy endpoint, a daily pain score.

 

[Dolphin]

Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment

TONMYA is now available by prescription and available for pharmacy ordering nationwide TONMYA is the first FDA-approved treatment for fibromyalgia in more...

www.globenewswire.com

Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment​

November 17, 2025 07:00 ET

 

[voner]

Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment

TONMYA is now available by prescription and available for pharmacy ordering nationwide TONMYA is the first FDA-approved treatment for fibromyalgia in more...

www.globenewswire.com

Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment​

November 17, 2025 07:00 ET

For USA pricing, I did a search on "GoodRX". current pricing is listed as $1850-$2150 for a one month supply. Welcome to the wonderful world of new drug pricing!

some Internet searching dug up a comment from Tonix Pharmaceuticals, the drug company selling this product. They said that it would be about mid 2026 before they expect to negotiate out lower pricing with USA private insurance companies…

i’d be really interested to hear the pricing on this drug in other countries when it gets get rolled out in other countries…

 

[Holinger]

For USA pricing, I did a search on "GoodRX". current pricing is listed as $1850-$2150 for a one month supply. Welcome to the wonderful world of new drug pricing!

.

Wow about 2 grand a month! Is it not chemically related to Amitriptyline which is 8 bucks a box? I have not read up on the evidence base yet.

 

[voner]

Wow about 2 grand a month! Is it not chemically related to Amitriptyline which is 8 bucks a box? I have not read up on the evidence base yet.

It is a reformularion of flexeril (cyclobenzaprine) - a common, inexpensive muscle relaxer pharmaceutical. The study is worth perusing. I do wonder what will be the price when it rolls out in other countries.

 

[Dolphin]

For what it is worth:

Station: YouTube & Proactive Investors
Date: November 24, 2025
WebTV:

Item: Tonix Pharmaceuticals launches Tonmya, a first-in-class non-opioid Fibromyalgia therapy