Tonmya™ A New Hope for Fibromyalgia Sufferers After 15 Years 

Originally shared in Episode 168 of the Fibromyalgia Podcast^®, this article has been adapted for readers of The Fibro Compass℠.

It’s the first new medication approved by the FDA for fibromyalgia in over 15 years.

Tami Stackelhouse, founder of International Fibromyalgia Coaching Institute, recently interviewed Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, on Episode 168 of the Fibromyalgia Podcast^®. Dr. Seth Lederman introduced the new FDA-approved medication, Tonmya™. This marks a significant milestone as it’s the first new medication approved by the FDA for fibromyalgia in over 15 years.

Dr. Seth Lederman's Background

Dr. Lederman earned his MD at Columbia Medical School, specializing in rheumatology and an AB in Chemistry from Princeton, graduating cum laude. With a rich background in research in immunology, infectious diseases, and autoimmune therapeutics, Dr. Lederman has dedicated over 30 years to the study of fibromyalgia because he understood how common fibromyalgia was and how poorly it was being treated. His passion for improving the lives of those affected by fibromyalgia led him to co-found Tonix Pharmaceuticals, where his work continues to make a profound impact.

The Introduction of Tonmya™

For those living with fibromyalgia, the introduction of Tonmya™ is a beacon of hope. Set to hit the market by the fourth quarter of 2025, Tonmya™ is the first new fibromyalgia drug approved by the FDA in 15 years. This non-opioid medication is administered as a cyclobenzaprine HCL sublingual tablet, which is placed under the tongue at bedtime. A common question has been: Is cyclobenzaprine, which is also recognized as Flexeril and can be prescribed for fibromyalgia, the same as Tonmya™? No, it is not the same. 

Per Dr. Lederman, “Flexeril is a swallowed tablet. When you swallow something, it goes into your stomach and basically has to pass through the liver to get into your bloodstream, and the liver transforms about half of Flexeril into something else before it even gets into your bloodstream. So what we did was we made a tablet that is put under the tongue and it gets into the bloodstream, it gets cyclobenzaprine into the bloodstream directly without going through the liver. And this is called transmucosal absorption, meaning it goes right across the mucosal surface. So by doing that, we decreased the amount of that metabolite that interferes with the effect.”

Cyclobenzaprine is a tricyclic muscle relaxant that has been used for decades to treat muscle spasms and associated pain. Tonmya™ is a new sublingual formulation of cyclobenzaprine designed to improve non-restorative sleep, thereby reducing fibromyalgia pain. 

Dr. Lederman was influenced by Dr. Harvey Maikin, who was on the scientific advisory board for Tonix. Dr. Maikin also proposed in 1975 that fibromyalgia be considered a disorder of non-restorative sleep. This became what they worked on for the drug to improve. Dr. Maikin passed away on the very same day that Tonmya™ was approved, August 15, 2025.

The FDA Approval Process

Securing FDA approval for a new medication is a rigorous and costly process, with no guarantee of approval. Over the 15 years that Tonix has been developing Tonmya™, they raised and spent more than $900 million, with each of their studies exceeded $12 million and taking an average of two years to complete. The FDA requires two adequate and well-controlled studies, which adds to the complexity and duration of the approval process. Fibromyalgia is a particularly challenging condition to study and treat due to its multifaceted nature and the variability of symptoms among patients. Researchers must carefully design studies to ensure they accurately assess the efficacy and safety of new treatments like Tonmya™.

Understanding Fibromyalgia and Nociplastic Pain

Fibromyalgia is a chronic pain condition that affects millions worldwide, characterized by widespread pain, fatigue, and cognitive difficulties. Dr. Lederman emphasizes the importance of increasing public awareness to align with advancements in scientific understanding. The recognition of nociplastic pain by the International Association for the Study of Pain represents a significant step forward in diagnosing and treating fibromyalgia. Nociplastic pain involves altered pain processing in the nervous system, which is a key factor in fibromyalgia.

As awareness grows among healthcare professionals, so does the potential for improved diagnosis and treatment. Enhanced understanding of nociplastic pain allows for more targeted and effective treatment strategies, moving beyond traditional pain management approaches. This progress is crucial for developing comprehensive care plans that address the unique needs of fibromyalgia patients, ultimately improving their quality of life.

Tonmya Together^TM Savings Program

There’s also a valuable cost-support option now available for adults with fibromyalgia who’ve been prescribed Tonmya™. The Tonmya Together™ Savings Program helps eligible commercially insured U.S. patients pay as little as $0 for their Tonmya™ prescription. Enrollment is quick and easy — you can check your eligibility and apply directly at tonmyasavings.com.

If Tonmya™ is part of your treatment plan, this savings program may help make your medication more affordable while you focus on feeling better.

Having trouble finding a pharmacy that can order Tonmya™?

If you’re struggling to find a pharmacy that can order Tonmya™, you’re not alone. Some large chains may not have it readily available to order yet. Certified Fibromyalgia Coach^® Kim Osborne did some extra digging for her clients and shared this tip:

If your usual pharmacy can’t order Tonmya™, Tonix recommends asking your doctor to send the prescription to BlinkRx (an online pharmacy service). If you’re eligible and commercially insured, BlinkRx may also be able to apply available savings through the Tonmya Together™ Savings Program.

Editor’s Note: We don’t have direct experience with BlinkRx and can’t recommend it one way or the other at this time.

Conclusion

The introduction of Tonmya™ is a promising development for the fibromyalgia community, representing a significant advancement in the treatment landscape. With ongoing efforts to increase awareness and understanding of fibromyalgia and nociplastic pain, the future looks brighter for those affected by this challenging condition. As Tonmya™ becomes available, it offers a new avenue of hope and relief for patients seeking effective treatment.

As awareness continues to grow, healthcare providers are better equipped to diagnose and treat fibromyalgia, leading to more personalized and effective treatment plans. The availability of Tonmya™ is a testament to the progress being made in the field, and it underscores the importance of ongoing research and advocacy.

With each step forward, the future looks brighter for those affected by this challenging condition. The introduction of Tonmya™ is not just a medical breakthrough; it is a symbol of hope and a catalyst for change in the lives of fibromyalgia sufferers.

Action Steps

If you or someone you know is affected by fibromyalgia, staying informed about the latest developments is crucial. Consider discussing Tonmya™ with your healthcare provider to explore whether it might be a suitable option for your treatment plan.

If you decide to try Tonmya™, here are a few points Dr. Lederman emphasized:

1. Don’t judge it by the starting dose. If you don’t notice much on one pill, that can be normal. The one-pill dose is typically a starting dose to help your body adjust. In the clinical trials, the improvements were seen at the higher dose of two pills at night.
2. Give it enough time. Results may take time. Consider committing to a trial of at least 14 weeks (the length of the study) before deciding whether it’s helping.
3. Tongue numbness can happen. If your tongue feels a bit numb, don’t panic. This can be a common side effect of the medication’s delivery system and isn’t necessarily a sign that something is wrong. Think of it like an injection that stings for a moment, or a liquid medication that tastes unpleasant.

Consider sharing this post to help spread awareness and support the fibromyalgia community. When we raise awareness and normalize conversations about fibromyalgia and its treatment options, it’s easier for people to find information, ask better questions, and feel less alone. Together, we can advocate for continued research and innovation—so those living with fibromyalgia receive the care, attention, and options they deserve.