On November 15, 2023 Tonix Pharmaceutical Holding Corp (Nasdaq: TNXP) announced the completion of Clinical Phase 3 study of TONMYA ™ (TNX-102 SL). Currently, there are three FDA approved medications for Fibromyalgia. It has been 15 years since the last medication was approved (Savella in 2009). To date there are still millions of people across the Globe struggling with the symptoms of Fibromyalgia, mostly Women. In the United States, Fibromyalgia affects an estimated 6-12 million people.

Clinical Phase 3 shows Significant Improvement of Symptoms

I was happy to learn that TONMYA ™ (TNX-102 SL) showed significant improvement of fibromyalgia in week 2 of the phase 3 clinical study. Furthermore, those improvements were consistent throughout the study (from week 2-14) and in all areas (sleep, fatigue, pain and brain fog). The even more exciting news is that TONMYA ™ (TNX-102 SL) is a sublingual tablet. I will explain why all of this should be major news in the fibromyalgia community. But before I go there, I need to address the reason why it isn’t and how that directly affects mental health.

Why People living with Fibromyalgia Feel Alone

Fibromyalgia is a nervous system disorder of unknown origin. Its primary symptoms are pain, fatigue and brain fog. Many recent studies have shown a possible connection to physical and/or emotional trauma. At times this can make our brains feel like they are in constant overload, making it difficult to achieve rem sleep. This vicious cycle can cause depression, isolation and learned helplessness. People who have lived with the disorder for multiple years begin to lose hope. For poor people struggling on limited incomes as a result of the disorder this adds an extra layer of despair. Not being able to live life as intended, attempting to keep up with social “norms” while trying to obtain human basic needs leaves them feeling beaten up, unseen, misunderstood and forgotten by their friends, families and society.

Who sits at the Fibromyalgia and Why?

Currently, there are many players at the fibromyalgia table. Some of which are worthy of a seat, then there are others who solely seek to capitalize from the community’s pain and suffering. People living on limited incomes have state issued Medicaid coverage which in most instances fully covers prescribed medications. These people cannot afford spa treatments, massages, and other therapies that have proven to help our more affluent counterparts. In many cases, the systematic injustice of poverty and fibromyalgia leaves people bedridden and isolated at home with no one outside to roll away the stone. This new medication can provide hope for those people, but no one is talking about it?

Who is Tonix?

Seth Lederman is the Chairman of Tonix Pharmaceuticals. He is an American Physician, Scientist and Pharmaceutical Entrepreneur. He has over 30 years of experience in the Rheumatology field and has been leading the efforts to bring this new medication to the fibromyalgia community since 2010. I met him and his team in 2015 when they came and spoke to our community at the first fibromyalgia awareness walk in New York City. I recently spoke with Seth and his team. They are excited to bring another option to the fibromyalgia community. He shared with me a presentation he recently made at a scientific conference. I am happy to share it with all of you.

Why I am excited about this new option

Before I share the reasons for my own personal excitement, I want to emphasize that I am PRO HEALING. Which means that whatever (legally) helps a person live their best life should be considered and never suppressed. It is inhumane to offer any less. I also feel the need to be 100% transparent in stating that I currently do not take any prescription medications. However, there was a time that I leaned on many to keep me functioning. 10mg of Cyclobenzaprine was a medication I used. However, I would often only take ½ of the tablet as the higher dosage would often cause me to feel groggy in the morning.

Moving on to the reasons for my excitement:

1. Clinical Phase 3 study showed improvement in all areas. Currently, no other fibromyalgia medication on the market has shown to help or improve all areas. Less medication seems like something we all should be happy about.

2. The sublingual form bypasses our gut. Many people living with fibromyalgia experience GI tract symptoms such as IBS, IBD, Crohns, etc…

3. The sublingual tablet provides faster absorption, making it ideal for bedtime and as a result helping to achieve rem.

4. The lower dosage ensures that people are taking the intended dosage as prescribed. Furthermore, the study proved improvement in sleep quality and did not decrease sleep quantity.

5. No recognized risk for abuse.

6. The study showed no effect on weight or blood pressure.

7. This medication is currently in Phase 2 study for Long Covid. It has the potential to help more people.

8. This medication is also currently in an investigator study for Acute Stress Reaction.

9. The study showed no sexual dysfunction and improved sexual functioning in its female participants.

As mentioned earlier, the people I serve through the Fibromyalgia Care Society of America, inc very often report the systematic injustices of poverty, mental health and pain. Those very often consists of being misunderstood by some of the people they love the most. This medication on the horizon has the potential to help many people and it is our duty to share that with all who can benefit the most. A sublingual medication showing Improvement in pain, fatigue, fog and sleep is more than hope. There is data to proves the legitimacy.

Improved Sexual Function-Oh My!

And in Simply Milly Fashion, I must add that I am currently single but can definitely relate to and understand how pain, fatigue and fibromyalgia can interfere with sexual functioning, separate families and affect our mental well-being. Improved sexual functioning sounds like a win-win for our partners too!

In Peace, Power and Progress!

Milly Velez

FCSA President and Executive Director

About the Author:

Mildred was born and raised in the Bronx, New York. Before her 18th birthday, she was able to check off all 10 points on a psychological assessment tool that gauges childhood trauma. She has survived rape, domestic violence, and homelessness. Her life experiences have propelled her to advocate for social and racial justice causes. Her career began in 1997 at a drop-in center for homeless young people ages 13-24. Mildred went on to lead the operations department of a Nationally Recognized LGBTQ+ youth shelter in New York City from 2002-2020. In 2015, She founded the FCSA in response to the lack of services for the fibromyalgia community. She is committed to using her personal and professional experiences to bring support, care, and hope to everyone living with fibromyalgia and their families.

Mildred currently lives with her adult children and granddaughter in the westward of the city of Newark, New Jersey. She enjoys spending time reflecting on past experiences and working towards a future where her children, grandchildren, and the communities that she serves are granted the same opportunities as neighboring towns and villages.

Fibromyalgia and Mental Health: A New Prescription Medication for Managing Fibromyalgia will soon be Available!