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.