The U.S. Food and Drug Administration has approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Developed by Tonix Pharmaceuticals, Tonmya is the first new FDA-approved fibromyalgia therapy in over 15 years. As a once-daily, non-opioid, sublingual treatment, Tonmya offers a novel option designed to reduce pain and improve sleep, two of the most disruptive symptoms experienced by patients living with fibromyalgia. DelRicht Research supported this important approval through a coordinated clinical trial effort across multiple high-performing sites.

DelRicht Research: Advancing Fibromyalgia Care Through Clinical Trial Leadership

DelRicht Research contributed to Tonmya’s FDA approval by conducting pivotal clinical trials across several embedded research sites. Our study teams were led by:

Dr. Robert Springer – Springer Wellness and Restorative Health, Atlanta, GA
Dr. Taylor Sanders – Neighborhood Health, Prairieville, LA
Dr. E. Marshall Newton – Newton Family Medicine, Charleston, SC
Dr. Jennifer Zomnir – Zomnir Family Medicine, Prosper, TX
Dr. Sean Kerby – Gulfport Memorial, Gulfport, MS
Dr. Patrick Dennis – Touro Medical Center, New Orleans, LA
Dr. Rachael Murphy – The Murphy Clinic, Mandeville, LA
Dr. Melita Tate – Grassroots Healthcare, Tulsa, OK

Together, these investigators helped evaluate Tonmya’s safety, tolerability, and clinical impact across a diverse population of adults living with fibromyalgia.

A New Option for a Long-Underserved Population

Fibromyalgia affects an estimated 10 million adults in the U.S., the vast majority of whom are women. Symptoms like widespread pain, poor sleep, fatigue, and cognitive difficulties can severely impair daily functioning and quality of life. For over a decade, treatment options have remained limited, with many patients cycling through medications that offer only modest relief or cause unwanted side effects.

Tonmya represents a first-in-class treatment with a distinct mechanism: it targets nonrestorative sleep, which is believed to worsen pain sensitivity in fibromyalgia. Delivered via sublingual tablet at bedtime, Tonmya is designed for rapid absorption and reduced liver metabolite buildup, contributing to its favorable tolerability profile in Phase 3 trials.

A Major Step Forward for Millions of Patients

“The approval of Tonmya™ marks a major step forward for millions of Americans living with fibromyalgia,” said Tyler Hastings, Managing Partner at DelRicht Research. “We’re proud of our investigators’ contributions to this approval and excited to support a treatment that offers new hope to patients who have waited far too long for innovation.”

“The approval of Tonmya™ marks a major step forward for millions of Americans living with fibromyalgia. We’re proud of our investigators’ contributions to this approval and excited to support a treatment that offers new hope to patients who have waited far too long for innovation.”

— Tyler Hastings, Managing Partner at DelRicht Research

The Power of Partnership and Progress

DelRicht Research remains committed to partnering with sponsors and investigators to accelerate therapeutic breakthroughs for chronic pain conditions. The approval of Tonmya underscores the value of embedded site models that deliver high-quality data, diverse enrollment, and operational speed.

To learn more about Tonmya, visit www.tonixpharma.com or read the full press release.

Congratulations to the team at Tonix Pharmaceuticals and to all the patients, investigators, and research staff who made this possible.