PTSD Study to Start in January

PTSD Study to Start in January

By Ed Coghlan

The National Institutes of Health defines Post Traumatic Stress Disorder (PTSD) as what develops in some people who have experienced a shocking, scary, or dangerous event.

By its very definition, PTSD is a huge problem for active military and military veterans.

Tonix Pharmaceuticals (NASDAQ-TNXP) believes its technology is something that can address that important and (what many believe is an) underdiagnosed group for PTSD. It’s estimated that 8.6 million people have PTSD. Tonix CEO Dr. Seth Lederman thinks it might be twice that. He’s not alone.

For civilians, and that includes many chronic pain patients, PTSD can develop after an auto accident, being the victim of a crime, or other traumatic events. For military, they essentially live in traumatic settings. In fact, Dr. Lederman says that up to 20% of Iraq and Afghan vets are believed to suffer from it.

“It’s an international problem,” he said.

Tonix has already had some success with its TNX-102 SL ((cyclobenzaprine HCl sublingual tablets). 180 PTSD sufferers who are in the military or veterans will be eligible for a study at 30 sites. The study will begin enrolling in January and by the end of 2017 the company should know if it has a winner.

“We’re betting the company on it,” Dr. Lederman declared.

You may remember Tonix Pharmaceuticals, particularly if you suffer from fibromyalgia. They recently announced they were discontinuing their fibromyalgia trial with TNX-102 SL. There was an imbalance in patient discontinuations for reasons unrelated to efficacy or tolerability (for example, a patient relocating away from the clinical site), creating a negative bias in the primary responder analysis due to any patient leaving the study.

Discontinuing that study still rankles the CEO who is a rheumatologist that believes it is an answer for fibromyalgia because of its ability to let the patient experience restorative sleep. The hard truth is that the Company doesn’t have enough money to continue to pursue it currently.

In September, he said in a company press release, “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.”

What has Dr. Lederman and the Tonix team feeling confident about the opportunity, is a Phase 2 study that was announced in May that showed good activity in treating the unmet needs of PTSD in military and veterans.

Last week, Tonix hosted a Posttraumatic Stress Disorder (PTSD) Awareness Day. A live webcast and subsequent replay of the event is available on Tonix’s website. To access the webcast, you can visit the Events tab of the Investor Relations section of Tonix’s website at www.tonixpharma.com.

There are four clusters of symptoms for PTSD:

  • Intrusion which is what happens when painful memories come back.
  • Avoidance which is when sufferers try to avoid trigger experiences like loud noises (to name one).
  • Hyperarousal when the body starts to experience high blood pressure, a high pulse rate and/or scanning the room for danger signs—and, recently, reckless and self-destructive behavior has been added to this symptom.
  • Mood Incognition which often manifests in depressive symptoms and the sufferer has an inability to connect.

Lederman pointed out that advocacy for patients with PTSD is still in its infancy. One well known effort is 22Kill.com which is trying to build awareness. The name of the group is derived from the fact that 22 active military and veterans commit suicide each day.

For Tonix, and those vets, this study provides real hope.

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Authored by: Ed Coghlan

There are 2 comments for this article
  1. Laurie Otto at 7:07 am

    I have to comment AGAIN.
    This actually isn’t the worst idea!
    But it sure is complicated to give Flexeril (name brand if med) a try on patients NOW and see if it works (it’s a muscle spasm med commonly prescribed in non-sublingual form for back spasm and has been helpful for me with injury recovery).
    Seems like PTSD is ANOTHER mostly ignored group of almost ALL HUMANS AT SOME STAGE IN LIFE. It’s not addictive medication and DOES have an initial “knock you out, asleep” side effect before you get used to it.
    I’m just a patient who would try this without the big fuss (up to the safety dose sizes it comes in already), and I might consider a name change on a company using all the letters in the word TOXIN mixed up. Most of us kratom users ARE treating depression, anxiety, and PTSD. Having been on flexeril for a short bit of that time for an injury, it might very well have complimented my improvements (much credit ALSO being given to cognitive behavioral therapy). A placebo might get good results, so I will follow this for my own PTSD interest and hope it works. Too bad about the fibromyalgia study. Blaming one trial participant seems a bit hasty. How can it possibly kill the entire trial to have ONE PERSON quit?! I would suggest preventive measures be utilized to avoid that being an issue (life happens, even during clinical trials. Do they get mad at RATS for not eating their samples, too? (“We must quit the fibromyalgia study. One rat burrowed out and made baby rats in the cage next door”, phooey) :)? Just light humor.
    Great story!