Big News for the Fibromyalgia Community: A New FDA-Approved Treatment Is Here

 

After more than 15 years without new treatment options, there’s finally a breakthrough: the U.S. Food and Drug Administration (FDA) has approved Tonmya™, a new medication specifically for fibromyalgia.

What Is Tonmya?

Tonmya (cyclobenzaprine HCl) is a non-opioid, once-daily tablet that you take under the tongue at bedtime. It’s designed to absorb quickly and help reduce pain while also targeting one of fibromyalgia’s most stubborn symptoms: nonrestorative sleep—that feeling of waking up tired no matter how long you’ve slept.

What Did the Research Show?

Tonmya was tested in three major clinical trials involving over 1,400 people with fibromyalgia. The results were promising:

• People taking Tonmya reported significant reductions in daily pain compared to those taking a placebo.

• Many participants experienced a 30% or greater improvement in pain after three months.

• The medication was generally well tolerated. Some reported mild side effects like mouth numbness, dry mouth, drowsiness, or canker sores.

Why This Matters

Fibromyalgia affects over 10 million adults in the U.S., most of whom are women. It’s a complex condition that causes widespread pain, fatigue, sleep issues, and cognitive challenges. For years, treatment options have been limited and often ineffective. Tonmya’s approval offers renewed hope for those who’ve felt unheard and underserved.

As Dr. Sharon Waldrop, a person living with fibromyalgia, shared:

“This approval is a promising step forward and brings renewed hope to millions.”

When Will It Be Available?

Tonmya is expected to be available in the U.S. by late 2025. If you’re interested in learning more or speaking with your healthcare provider, you can visit Tonix Pharmaceuticals.

If you’ve been living with fibromyalgia and feeling like nothing helps, this news might feel like a small light at the end of a long tunnel. It’s okay to feel cautious, curious, or even hopeful. You deserve options, and you deserve care that sees the full picture of your experience.