RESILIENT Phase 3: Tonix Press Release Summarizes TONMYA Efficacy and Tolerability

Tonix Pharmaceuticals’ March 2026 press release reports Phase 3 RESILIENT trial results for TONMYA (cyclobenzaprine HCl sublingual tablets) in adults with fibromyalgia. The company states the study met a statistically significant difference versus placebo on mean daily pain at Week 14, and that a higher proportion of participants receiving TONMYA achieved a ≥30% reduction in daily pain compared with placebo. The release also describes TONMYA as generally well tolerated and references additional analyses presented alongside the main findings.

According to the press release, RESILIENT was a 14-week, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of TONMYA in 457 patients who met the 2016 American College of Rheumatology diagnostic criteria for fibromyalgia. The release identifies the primary efficacy endpoint as mean daily pain at Week 14, reported as a between-group comparison versus placebo.

In addition to the primary endpoint statement, Tonix reports more individuals achieved a 30% reduction in daily pain with TONMYA than with placebo. The release describes this level of improvement as “considered a clinically meaningful response."

For adverse reactions, the press release lists events occurring at a higher incidence with TONMYA than placebo and with incidence ≥2%: oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer. Tonix states these were predominantly mild and self-limited oral cavity reactions, occurred more frequently than placebo, and uncommonly led to study withdrawal.

Tonix also states that a copy of the company’s poster presentation is available under the Presentations tab on the Tonix website. Overall, the release emphasizes Week 14 pain findings, a ≥30% responder summary, and a qualitative tolerability profile.

Key Takeaways:

• Tonix’s press release states that the Phase 3 RESILIENT trial met a statistically significant difference versus placebo on mean daily pain at Week 14, without presenting the numeric effect size or p-value in the body text.
• The company also reports a higher proportion of TONMYA-treated participants achieved a ≥30% reduction in daily pain versus placebo, described in the release as a “clinically meaningful” response.
• Common adverse reactions listed in the release were primarily oral cavity-related (plus somnolence, fatigue, and dry mouth), characterized as mostly mild/self-limited and uncommonly leading to withdrawal.