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

Dolphin

Dolphin

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


I'll check with clinical trials.gov and see if any publication of trial details exists. It's a sleep architecture agent (might be useful for ME/CFS sleep dysfunction?, possibly). I assume it increases Stage 4 or deep sleep, where muscle repair takes place among other things.

The placebo control blinding drug would have to cause some mouth side effects. One might sense being in a placebo group if the placebo drug didn't cause any fatigue. I'll check to see what they used.

A greater than or equal to 30% reduction in pain due to actions on neurotransmitters was captured with an 11-question survey at 14 weeks. I have to assess that instrument and frequency of administration to research sujects (n=1000).

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).

The investor call link above is interesting regarding the pharmaceutical industry. This drug might make investors some money.....for a while. I will probably give it a try when it's available.
 
Last edited:

ClinicalTrials.gov

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.)
 
You must log in or register to reply here.
Back
Top Bottom