Tonix Pharmaceuticals presented data on TONMYA (cyclobenzaprine HCl sublingual tablets), a new fibromyalgia treatment, at the 2026 American Academy of Pain Medicine PainConnect Annual Meeting in Salt Lake City. TONMYA is the first approved therapy for fibromyalgia in over 15 years and was approved by the FDA in August 2025, with commercial launch occurring in November 2025.
Clinical Trial Results
Data from the Phase 3 RESILIENT trial, a 14-week randomized, double-blind, placebo-controlled study with 457 patients, showed that TONMYA treatment resulted in statistically significant reduction in mean daily pain at 14 weeks. The therapy also increased the proportion of individuals with a 30% reduction in daily pain compared to placebo—a clinically meaningful response. The most common adverse events were mild and self-limited oral cavity reactions that uncommonly led to study withdrawal.
How TONMYA Works
TONMYA uses a patented sublingual formulation of cyclobenzaprine that allows rapid absorption and bypasses first-pass hepatic metabolism. This design reduces the production of norcyclobenzaprine, an active metabolite with a long half-life that researchers believe interferes with cyclobenzaprine’s durability in long-term fibromyalgia treatment. The sublingual formulation addresses a limitation of oral cyclobenzaprine, which provided only short-term benefit insufficient for treating this chronic condition.
Fibromyalgia Context
Fibromyalgia affects an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. The condition results from amplified sensory and pain signaling within the central nervous system and presents with chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. TONMYA represents an alternative to three currently FDA-approved medicines, which are limited by side effects, adherence issues, and high discontinuation rates.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://menafn.com/1110838595/Tonix-Pharmaceuticals-Presented-Data-On-TONMYATM-In-Treating-Patients-With-Fibromyalgia-At-The-2026-AAPM-Painconnect-Annual-Meeting