Phase 3 data for TNX-102 SL in fibromyalgia

TNX-102 SL may become the first new fibromyalgia treatment in 15 years

Tonix Pharmaceuticals presented phase 3 data for TNX-102 SL at the 7th International Congress on Controversies in Fibromyalgia in Vienna, Austria. “Since fibromyalgia is a chronic pain condition, medicines to treat fibromyalgia need to provide durable benefits,” said Seth Lederman, Chief Executive Officer of Tonix Pharmaceuticals. The sublingual formulation of cyclobenzaprine, designed for bedtime use, showed durable pain reduction by targeting non-restorative sleep.

What is TNX-102 SL, and how is it delivered?

TNX-102 SL is a sublingual tablet formulation of cyclobenzaprine. It is designed for rapid transmucosal absorption at bedtime, bypassing first-pass hepatic metabolism and reducing formation of the active metabolite norcyclobenzaprine.

What did the phase 3 trials show?

Two 14-week, double-blind, randomized, placebo-controlled phase 3 trials demonstrated that TNX-102 SL 5.6 mg significantly reduced daily pain compared with placebo. The treatment was generally well tolerated, with no new safety signals observed.

How does TNX-102 SL compare with oral cyclobenzaprine?

Unlike oral cyclobenzaprine, which showed no durable benefit beyond 1 month, TNX-102 SL demonstrated statistically significant pain reduction sustained over 3 months. This is attributed to its delivery method and reduced norcyclobenzaprine formation.

What is the mechanism of action?

TNX-102 SL targets non-restorative sleep, a key contributor to fibromyalgia pain. Its pharmacokinetic profile aligns with the sleep cycle and avoids accumulation of norcyclobenzaprine, which may limit the efficacy of oral formulations.

What is the regulatory status of TNX-102 SL?

The FDA has set a PDUFA goal date of August 15, 2025, for a decision on marketing authorization. If approved, TNX-102 SL would be the first new treatment option for fibromyalgia in 15 years.