FDA Assigns PDUFA Date for TNX-102 SL, a Nonopioid Analgesic for Fibromyalgia

The US Food and Drug Administration (FDA) has assigned August 15, 2025, as the Prescription Drug User Fee Act (PDUFA) goal date for a decision on marketing approval for TNX-102 SL (cyclobenzaprine HCl), a nonopioid, centrally acting analgesic under development for the management of a fibromyalgia, according to a company news release.

“We look forward to working closely with the FDA throughout the review period in advance of the August 15, 2025, PDUFA goal date,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe that TNX-102 SL has the potential to be the first member of a new class of medicines for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the U.S. Data from our pivotal Phase 3 trials support that TNX-102 SL can provide fibromyalgia patients with significant reduction in pain with favorable tolerability, helping to address the significant unmet need in this community.”

TNX-102 SL previously received Fast Track designation in July 2024 for fibromyalgia. Fast Track status is intended to expedite the FDA review process for new drugs that address serious conditions with unmet needs.

The New Drug Application (NDA) under review is supported by findings from two 14-week double-blind, randomized, placebo-controlled Phase 3 clinical trials. In the RELIEF trial, completed in December 2020, TNX-102 SL 5.6 mg achieved the primary endpoint of significantly reducing daily pain compared with placebo (P=0.010). The confirmatory RESILIENT trial, completed in December 2023, again showed that TNX-102 SL significantly reduced daily pain (P=0.00005). Adverse events were generally mild, with the most common event being transient tongue or mouth numbness at the administration site.

Fibromyalgia is a common chronic pain condition characterized by widespread pain, nonrestorative sleep, fatigue, and cognitive dysfunction. The condition affect millions of individuals in the United States, with a majority of diagnosed cases occurring in women.It is understood to result from amplified sensory and pain signaling within the central nervous system, a process known as central sensitization. Current treatment options often leave many patients dissatisfied, highlighting an unmet need in this population.

References

1. Tonix Pharmaceuticals Announces PDUFA Goal Date of August 15, 2025 for TNX-102 SL for Management of Fibromyalgia. Press release. December 23, 2024. Accessed January 2, 2025. https://ir.tonixpharma.com/news-events/press-releases/detail/1542/tonix-pharmaceuticals-announces-pdufa-goal-date-of-august

2. National Council on Aging. Fibromyalgia Facts and Statistics. Accessed January 2, 2025. https://www.ncoa.org/adviser/sleep/fibromyalgia-facts-and-statistics