Segal Trials announced its participation as a clinical research site in the pivotal studies that supported the U.S. Food and Drug Administration’s (FDA) approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. This milestone, announced by Tonix Pharmaceuticals, marks the first new FDA-approved therapy for fibromyalgia in more than 16 years.

Dr. Olga Lapeyra, Principal Investigator at Segal Trials, provided leadership during the study.

“Fibromyalgia has long been a condition with limited treatment options, leaving patients and families searching for relief,” said Dr. Lapeyra. “This approval represents renewed hope for the millions of individuals who live with this disorder. To see a new option come forward after more than 16 years is inspiring. It is an honor for our team to contribute to this advancement, and I am grateful to the patients who volunteered. Their involvement makes progress possible.”

Through its enrollment efforts, Segal Trials emphasized the importance of including a diverse range of participants. Drawing on its expertise in patient recruitment, the organization engaged individuals across South Florida, creating opportunities for patients to take part in research. This approach reflects Segal’s commitment to making clinical trials accessible and patient-centered.

The FDA approval was supported by two Phase 3 clinical trials enrolling nearly 1,000 patients across the U.S., which demonstrated that Tonmya significantly reduced daily pain scores and improved sleep quality compared to placebo, with a favorable safety profile.

About Segal Trials

Segal Trials is a privately held clinical research network headquartered in South Florida, operating five state-of-the-art facilities dedicated to advancing medical science and improving patient outcomes. Founded in 1998 by Bonnie Segal and Scott D. Segal, M.D., Segal Trials specializes in Phase I–IV clinical trials across psychiatry, neurology, women’s health, addiction, infectious diseases, psychedelics research, general medicine, and healthy volunteers.

With more than 65 FDA-approved drugs and devices resulting from studies conducted at its sites, Segal Trials has partnered with pharmaceutical leaders including Merck, Roche, Bristol Myers Squibb, Teva, AbbVie, Biogen, Johnson & Johnson, AstraZeneca, Bayer, Novartis, Seelos, Pfizer, Cybin, and Usona

Today, Segal Trials employs over 100 professionals and continues to expand its capabilities while staying true to its core values of quality, patient care, advocacy, and service to sponsors.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250909045493/en/

“This approval represents renewed hope for the millions of individuals who live with this disorder."