Fibromyalgia Drug Study To Be Discontinued

Fibromyalgia Drug Study To Be Discontinued

By Ed Coghlan

Some bad news for the millions of fibromyalgia patients hoping there might an answer to getting more restorative sleep.

Tonix Pharmaceuticals is going to discontinue the study of its TNX-102 SL, which held—and may still hold—great promise for addressing the fibromyalgia sleep issue.

The data did not achieve statistical significance in the primary efficacy endpoint: the proportion of patients who reported a 30 percent or greater reduction in pain from baseline to the end of the 12-week treatment period based on the pre-specified primary analysis. However, TNX-102 SL did show statistically significant effects on pain when analyzed by other standard statistical approaches. TNX-102 SL activity in fibromyalgia was cross-validated by two additional endpoints, Patient Global Impression of Change and Fibromyalgia Impact Questionnaire-Revised. These endpoints assess global improvement and a range of fibromyalgia symptoms and function. TNX-102 SL showed strong effects on improving sleep quality by the daily diary and the PROMIS sleep disturbance scale. The internal consistency of these results provides clear evidence of beneficial effect of TNX-102 SL for the treatment of fibromyalgia.

In any FDA trial, follow-up with patients is critical in order to assess efficacy. And follow-up became a challenge in this study.

An unexpected imbalance in patient discontinuations for reasons unrelated to efficacy or tolerability (for example, a patient relocating away from the clinical site. It created a negative bias in the primary responder analysis because any patient who left the study, for any reason prior to completion, was labeled a non-responder despite their results up to that point.

“TNX-102 SL showed broad beneficial effects across key fibromyalgia symptoms and was well-tolerated in the AFFIRM study. Despite achieving clinically meaningful results from AFFIRM, we have greater clarity on the regulatory path forward in our PTSD program. We will therefore discontinue the fibromyalgia program in order to fully focus Tonix’s resources on advancing our potential breakthrough PTSD program to Phase 3,” said Seth Lederman, M.D., Tonix president and chief executive officer.

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Authored by: Ed Coghlan

There are 7 comments for this article
  1. Jean Price at 4:19 pm

    What?! Well the extended release flexeril is over $1000.00 a month so maybe it’s better they stopped this if it is just flexeril!!

  2. HJ at 1:37 pm

    Clarification: I was on FLEXERIL. I was never on the trial version of the TNX drug (which is a low-dose version of Flexeril)

  3. HJ at 1:25 pm

    Well, the TNX that they were reporting on was described as a low dose of flexeril… sublingual, if I remembered (melts under tongue). I distinctly remember it being flexeril (generic: cyclobenzaprine) but my memory could be wrong on the sublingual part but I guess that’s what the “SL” is to indicate.

    I was on it for a number of years. It was the very first muscle relaxant I was on. The rheumatologist who put me on it was very keen on getting me on an anti-depressant and I did try Cymbalta, Effexor and I ended up on Prozac for which helps with PMDD and Migraine headaches as well as the dysthmia that does result from the burden of multiple health issues.

    The need for the muscle relaxant for me was initially for sleep. Sometimes we aimed for a more stimulating drug (Cymbalta, Effexor) for daytime use for energy. I also had a torn disc (annular tear) in my lower back and the spasms that resulted from that were helped by a muscle relaxant. Then, came the cervical spondylosis. Trigger point injections and physical therapy… the flexeril’s utility became very limited. Aspercreme helps to a degree, so does an accupressure mat (mostly for my lower back).

    That’s when we switched to Baclofen. It’s keeping the headaches at bay. The muscle tightness is still rather pronounced. I rub Aspercreme on it and I get by.

    I turned 37 last month. My mother has had two back surgeries for aggressive osteoarthritis. I have OA in my feet, ankle, knee(s?), hips, SI Joint, Degenerative Disc Disease, Cervical spondylosis and more OA in my shoulder(s?) and hands. I wish lawmakers paid attention to stories like these. I try to share the abbreviated version. Here, I know people understand… have been there. Most “normal” people don’t understand more than acute pain or surgical pain… chronic, life-changing, near-constant pain is beyond fathoming.

    I hope others will share their experience with flexeril/cyclobenzaprine so you can get a more representative response. It wasn’t that it wasn’t useful…

    … it was that the super-low dose didn’t seem like anything new and very likely wouldn’t help me since the 10mg dose of flexeril has become grossly inadequate. I was taking 30-40mg when it ceased being useful. (I’d cut back if I was overly-groggy)

  4. Debbie Oliver at 12:25 pm

    I’m currently in a fibromyalgia clinical study in Los Angeles and have just been given the test medication. There was no indication that this particular study would be discontinued I’m not sure if medication that I’m taking is the medication indicated in this article. Is this a nationwide study or in just particular States?

  5. HJ at 4:57 am

    Oh, so they’re not going to charge brand-name copays for a re-formulation of Flexeril? Oh, darn.

    Frankly, that’s good news. Flexeril is still on the market as a generic for anyone who might benefit from it. Granted, it’s not the low dose they were going to re-brand as a “new thing.”

    I took Flexeril for years but it basically made me tired until it didn’t do even that. They have me on Baclofen now, and it helps. It’s by no means a miracle, but I’m glad for some relief of my cervical spondylosis. It keeps the cervico-genic headaches mostly at bay.

    My mother has spinal issues and said that Zanaflex helps her a lot. My prescriber seems reluctant to try it. I looked into my insurance coverage a few years ago, and a (generic) tablet was covered but the (generic) capsule wasn’t… something like that. Well, as long as the baclofen keeps the (once-)daily headaches away most of the time, I’m not going to ask to change medications. I’m glad there may be other options if I need them.

  6. Joan Hamm at 3:59 am

    How many people have tried the TNX??? To prove your results?