Monday, June 23, 2014

Interview with Dr. Seth Lederman CEO of Tonix Pharmaceuticals

One of the things I enjoy the most about blogging is that I get a chance to talk with some of the most fascinating and brilliant people who are passionate about helping chronic pain sufferers. Recently I've had the pleasure of talking with Dr. Seth Lederman, a rheumatologist and CEO of Tonix Pharmaceuticals.

I have been interested in Tonix for quite some time and had posted a blog entry on 6/28/12 about their initial study for chronic pain sufferers. Their initial target was for Fibro and Post Traumatic Stress and it was going to focus on a medicine geared towards restful sleep that was opiate-free and non-addictive.

Tonix Pharmaceuticals, known as TNXP on Nadaq, as of August 2013, is a rapidly growing company that was founded in 2007 and went to public trade in 2011. It is currently boasting two sites with 13 employees. Manhattan, NY is their main base and San Jose, CA is where they do clinical developmental research.

The drug, which is now in phase 2 of testing, is known by the name of TNX-102SL, and is a tablet that dissolves under the tongue that is taken at bedtime. If this drug does well in trials it will change the landscape for many sufferers because there is currently not much available to help the sufferer that can be taken at night right before bed.

I asked Dr. Lederman why some of the drugs available today don't work for everyone. "I have a great respect for Cypress, Eli Lilly, and Pfizer because their drugs changed the landscape for Fibromyalgia sufferers. It is a much better place for patients today than it was before drugs like Lyrica. But these drugs don't work for everyone. About 40% will respond to the similar drugs Cymbalta and Savella. And about another 40% respond to Lyrica. Tolerability is the key. We hope our drug will help the others give them the help they need."

I also asked Dr. Ledermen about exercise and how it can play a role in helping chronic pain sufferers' treatment. "Yoga is wonderful for Fibromyalgia patients, however, many just simply can't exercise due to the pain, but with the help of this drug, perhaps they can. We also hope it doesn't stop there, though. We hope that other drugs will develop if this is effective."

Drugs like Lyrica, Cymbalta and Savella are taken during the day to target pain. TNX-102SL will focus on patient's sleep and hopefully allow them to have a more restorative sleep. Many people with Fibromyalgia are light sleepers and will feel like they haven't slept at all when they wake up in the morning. Their body may have slept, but it was not a refreshing sleep where they are full of energy in the morning. Often they feel groggy, stiff, and in pain. "A fibro suffer typically does not have trouble falling asleep or even staying asleep, but they do not feel refreshed. It's tough though because sometimes it's a chicken and egg thing. (As a doctor) you have to ask, 'Are you not sleeping because you are in pain or are you in pain because you have not slept?'"

Dr. Seth Ledermen went on further with the subject of sleep stating, "Often times a doctor will hear from a patient, 'Doc, I can't sleep.' Many will take the patient's words at face value and believe they have an issue with insomnia where they can't fall asleep at night. And really as a doctor, we should focus on sleep more. You spend a third of your life sleeping, so a doctor should spend a third of the visit talking about sleep by asking questions like, 'Do you have trouble falling asleep, do you wake up and have trouble falling back to sleep, or do you wake up not feeling refreshed."

Phase 2 trials of TNX-102SL should hopefully conclude soon and we will hopefully see the findings before the end of this year, early next.

It was an absolute joy to talk with Dr. Seth Ledermen and I hope that once the clinical tests are published that I can chat with him again to keep you all informed about this exciting drug.

Stay fabulous!
Love and friendship,

Kimberley
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