Big News for Fibromyalgia: First New Treatment in Over a Decade

Hi Friend,

I hope you are well, some massive news for fibromyalgia patients this week!

The Big News

For the first time in more than 15 years, people living with fibromyalgia finally have a brand-new treatment option. On August 15, 2025, the U.S. Food and Drug Administration (FDA) approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia-related pain in adults.

This is a landmark decision for the fibromyalgia community, where progress has been painfully slow and treatment options limited. Existing drugs such as Lyrica (pregabalin), Cymbalta (duloxetine), and Savella (milnacipran) have been the only FDA-approved options since the mid-2000s. While they help some patients, many experience only partial relief or intolerable side effects.

Tonmya breaks new ground by tackling one of fibromyalgia’s most overlooked but powerful drivers: non-restorative sleep.

🔬 What Exactly Is Tonmya?

At its core, Tonmya is a low-dose, under-the-tongue (sublingual) version of cyclobenzaprine. Cyclobenzaprine isn’t new—it’s been used for decades as a muscle relaxant—but this unique formulation works differently.

• Sublingual delivery means Tonmya dissolves under the tongue and is absorbed rapidly, avoiding heavy metabolism in the liver and reducing unwanted by-products that cause grogginess.

• Taken at bedtime, Tonmya is designed to improve sleep quality, which in turn helps to lower pain sensitivity and fatigue the following day.

• Multi-pathway action: It works on key brain receptors—serotonin (5-HT2A), adrenergic (α1), histamine (H1), and muscarinic (M1)—all of which influence sleep, pain perception, and arousal.

This approach is different from “numbing pain” with strong drugs. Instead, Tonmya works by resetting the sleep-pain connection, which has been at the heart of fibromyalgia research for years.

📊 The Research Behind It

Tonmya’s approval wasn’t a fluke. It came after two major Phase 3 clinical trials:

• RELIEF Trial and RESILIENT Trial, enrolling nearly 1,000 fibromyalgia patients.

• Results showed:

  • Significant daily pain reduction over 14 weeks.

  • 20% of patients achieved ≥30% reduction in pain, while around 10% achieved ≥50% reduction.

  • Notable improvements in sleep quality, fatigue, cognitive function (“fibrofog”), and even sexual health.

One of the biggest findings? Benefits began as early as week 1, with sustained improvement through 14 weeks.

For a condition where patients are used to slow or no progress, that’s game-changing.

⚠️ Side Effects: What Patients Can Expect

Tonmya’s side effect profile is considered relatively mild compared with current fibromyalgia drugs:

• Most common:

  • Mouth or tongue numbness (~24%)

  • Altered taste (~12%)

  • Tingling sensations (~7%)

• Less common: Headache or daytime sleepiness (~2%)

• Importantly: It does not typically cause weight gain, dizziness, nausea, GI upset, or sexual dysfunction—all of which can be problematic with older drugs.

There are still precautions: Tonmya is chemically related to tricyclic antidepressants (TCAs), so people with heart rhythm problems, seizure disorders, or those on MAO inhibitors should avoid it.

⏰ When Will It Be Available?

• FDA Approval: August 15, 2025

• Launch Details Announced: August 18, 2025

• Expected Rollout (U.S.): Q4 2025 (October–December)

• First Prescriptions: Doctors in the U.S. could begin prescribing before the end of the year

🌍 What About the Rest of the World?

At present, Tonmya is only approved in the United States. No official applications have yet been announced for Europe, Canada, or other regions.

• Tonix has already presented Tonmya data at major European conferences, showing clear interest in international markets.

• The company is expected to submit regulatory applications in Europe, Canada, and other regions after the U.S. launch, which means international access is likely to begin in 2026 and beyond, depending on review timelines.

• Global rollout speed will depend on regional regulatory authorities (like EMA in Europe, Health Canada, MHRA in the UK) and how quickly Tonix can submit dossiers.

For now, U.S. patients will have first access—but the expectation is that Europe and other markets will follow within the next 1–2 years.

💡 Why This Approval Matters

Fibromyalgia affects an estimated 4 million adults in the U.S. alone (and millions more worldwide). Yet for decades, patients have been told to “just cope” with limited options. Many cycle through ineffective medications, lifestyle changes, and even disbelief from medical professionals.

The approval of Tonmya represents:

• Validation: Recognition that fibromyalgia is real, biological, and worthy of innovation.

• Hope: A new mechanism of treatment focused on sleep restoration rather than masking pain.

• Momentum: Renewed energy for research into fibromyalgia, long COVID, ME/CFS, and other conditions where sleep, fatigue, and pain overlap.

Just a quick one, I have opened up some more appointments for face to face and virtual slots in September, after this month my patient list will be closed until he new year. please click below for a appointment.

Final Thoughts

Tonmya may not be a miracle cure—but it’s a major step forward. For the first time in over 15 years, fibromyalgia patients and doctors can discuss a truly new option.

By improving sleep, Tonmya addresses a central piece of the puzzle—and for many, better nights could finally mean better days.

Availability starts in the U.S. late 2025, with Europe and other regions likely following in 2026 or later.

Kind Regards

Dr Ahmed