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Tonix Pharmaceuticals Launches Phase 3 Clinical Study of TNX-102 SL for Fibromyalgia

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AFFIRM Study to Enroll 500 Patients in Up to 35 U.S. Centers

NEW YORK, May 13, 2015 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (“Tonix”) announced today that it has begun a Phase 3 clinical study of TNX-102 SL (cyclobenzaprine HCl sublingual tablet, 2.8 mg) in fibromyalgia, having recently randomized the first patient. The study is expected to enroll approximately 500 patients with fibromyalgia at approximately 35 clinical centers in the U.S.

The randomized, double-blind, placebo-controlled “AFFIRM” study will evaluate the efficacy of TNX-102 SL taken daily at bedtime in improving pain, sleep quality, and other clinical measures, as well as the safety of TNX-102 SL. As accepted by the U.S. Food and Drug Administration (“FDA”), the primary outcome assessment for the study will be a pain responder analysis, defined as the proportion of patients who report at least a 30 percent reduction in pain from baseline at the end of the 12-week treatment period. Tonix expects to report top-line results from the AFFIRM study in the second half of 2016. To learn more, please visit (NCT02436096).

“Fibromyalgia is one of the most common chronic pain conditions, and yet despite approved medications, the majority of patients either do not respond to, or cannot tolerate, these products,” said Daniel J. Clauw, M.D., professor of anesthesiology, medicine (rheumatology) and psychiatry and director of the Chronic Pain and Fatigue Research Center at the University of Michigan, and a consultant to Tonix. “The efficacy and tolerability profile of TNX-102 SL as demonstrated in prior clinical evaluations supports this candidate as a promising treatment for fibromyalgia.”

“We are proud to be developing a new prescription medicine for people suffering from a condition that, despite its prevalence, remains inadequately addressed,” said Seth Lederman, M.D., chairman and CEO of Tonix. “If approved, we believe TNX-102 SL would offer a clinical profile that would be highly differentiated from currently-marketed drug products, and would be the first medicine for fibromyalgia to target non-restorative sleep.”

If you are interested in possibly participating in this clinical trial, visit

Source: Tonix Pharmaceuticals Press Release

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One thought on “Tonix Pharmaceuticals Launches Phase 3 Clinical Study of TNX-102 SL for Fibromyalgia”

  1. LadyWolf25 says:

    I am completely at a loss when drug companies are wasting there time on a drug that has been around and used for years in the past. Fexeril or Cyclobenzaprine is a good example of this. It was one of the first group of SSRI’s used on me in in treatment of Fibromyalgia/CFS. I feel as if your trying to reinvent the wheel and going backwards!!!
    The fact that this is being called a new drug whereas, it is one the oldest drugs on the market. Now I am baffled because you might change it to extended release or lower the dosage, the pharmaceuticals can call it a new drug?
    Please keep in mind, many of ME/CFS/FMS patients have been the guinea-pigs for years on SSRI type medications. It is now coming to light that there is a caution for those who are unable to tolerate antidepressant type medications or (Serotonin Syndrome.) This is why I am very Leary in taking SSRI’s or it’s sub-classes, avoiding them like the plague. Flexaril was one of the worst drugs I had ever taken! The side effects have been life altering, unable to sleep for days, the side effects were HORRIFIC the ACUTE onset of severe “VERTIGO”, was almost immediate, even after stopping the drug, the severity of vertigo continued for over nine long months. Finally one day it slowly went away, but I still experience bouts of it when it gets windy, or I walk into a dark room or after a couple days from insomnia.
    I feel strongly it was this drug that was the cause of it. If anyone has suffered from vertigo, believe me the nausea, confusion, dizziness and feeling like you are on a on a ship, with huge waves that never reaches land… I wanted to dye. Couldn’t move my eyes, when I went to bed I had to keep a light on, or I felt I was on a steep tilt. that was ocer 23 yrs ago. I still deal with it but not like the firts 9 mos after taking this drug. When I was in Kauai, I couldn’t look at the waves, or try to swim, due to the feeling of vertigo and keeping my balance.
    I just want to let Pharmaceuticals, Clinicians and Patients alike, to be very aware how dangerous SSRI’s can be to us. Please do an in-depth history of all drug side-affects with SSRI meds or if you have ever taken flexeril?

    Patients must do their homework, find out as much as you can, before putting your life at risk. We are very vulnerable when someone renames a drug, that is NOT a new drug. Do not jump into something unless you know the facts of what class it is and if you have ever had a bad reaction to it?
    We are so challenged by our symptoms, so eager when a new drug comes out for any relief. Please treat us with TLC. Be through and cautious. I have found out the hard way, how dangerous these can be for many patients. It is know well known, that antidepressant type drugs are really not that effective for ME/CFS/FMS patients, and it’s side affects out way the benefit. Their history and side affects of all SSRI antidepressant drugs should be carefully monitored in this study.


    Respectfully, Miss Collins

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