Tonmya met endpoints in RESILIENT trial

Tonmya significantly reduced pain and improved sleep in people with fibromyalgia

Tonix Pharmaceuticals presented data from its phase 3 RESILIENT trial at the Annual European Congress of Rheumatology (EULAR) 2024, held in Vienna, Austria. The poster, titled “Targeting Non-Restorative Sleep in Fibromyalgia with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) Significantly Improves Pain in RESILIENT, a confirmatory Phase III Randomized Clinical Trial,” showed that Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared with placebo. Tonmya also demonstrated statistically significant improvements across all six key secondary endpoints, including sleep quality, fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. “We are excited by the prospect of offering this patient population its potential first new therapy option in more than a decade,” said Seth Lederman, Chief Executive Officer of Tonix Pharmaceuticals.

What was the primary endpoint of the RESILIENT trial?

The primary endpoint was a reduction in daily pain in participants with fibromyalgia, which Tonmya met with statistical significance (P=0.00005).

What secondary endpoints did Tonmya meet in the RESILIENT trial?

Tonmya met all six pre-specified key secondary endpoints, including improving sleep quality, fatigue, and patient global ratings and overall fibromyalgia symptoms and function.

Were there any safety concerns reported with Tonmya?

Tonmya was well tolerated, with an adverse event profile comparable to prior studies and no new safety signals observed.

Did Tonmya show any additional benefits in exploratory analyses?

Yes, Tonmya improved depressive symptoms measured by the Beck Depression Inventory and female sexual function measured by the Changes in Sexual Function Questionnaire.

What are Tonix Pharmaceuticals’ next steps for Tonmya?

Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 and has scheduled a Type B pre-NDA meeting with the FDA for the second quarter of 2024.