Tonix Pharma Submits NDA for TNX-102 SL, Potential Fibromyalgia Medication

Credit: Adobe Stock

Tonix Pharmaceuticals has submitted a new drug application (NDA) for its non-opioid, centrally acting analgesic TNX-102 SL for the proposed treatment of fibromyalgia.¹

“With the submission of this NDA, Tonix has achieved a critical milestone in potentially bringing a new first-line treatment option to the large and dissatisfied fibromyalgia population that has not had a new pharmacotherapy in over 15 years,” Seth Lederman, MD, Chief Executive Officer, Tonix Pharmaceuticals, said in a statement.¹ “TNX-102 SL would be the first member of a new class of medicines for treating fibromyalgia. TNX-102 SL was designed and developed as a bedtime treatment to be taken daily on a chronic basis. Tonix believes bedtime TNX-102 SL relieves fibromyalgia pain by targeting the non-restorative sleep that is characteristic of fibromyalgia.”

TNX-102 SL is a cyclobenzaprine hydrochloric acid sublingual tablet medication. It was previously granted Fast Track designation for fibromyalgia by the FDA in July of 2024. Cyclobenzaprine interacts as an antagonist at 4 different receptors in the brain: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors, and may target the non-restorative sleep characteristic of fibromyalgia.

Tonix’s NDA submission is supported by data from 2 Phase 3 studies that demonstrated statistically significant reductions in the chronic, widespread pain associated with fibromyalgia. The phase 3 RELIEF and RESILIENT trials were 14-week, double-blind, randomized, placebo-controlled trials that evaluated the safety and efficacy of TNX-102 SL 5.6 mg as a bedtime treatment for fibromyalgia.

RELIEF met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo (P = .010) and was completed in December 2020. RESILIENT met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (P.= .00005 and was completed in December 2023.²

TNX-102 SL was generally well-tolerated in both trials and its safety profile was comparable with that seen in prior studies with no new safety signals. The most common treatment-emergent adverse event (AE) in both pivotal studies was tongue or mouth numbness at the administration site temporally related to dosing, although this was self-limited and not severe, although 1 participant in each study chose to discontinue due to the AE

“Despite 3 FDA-approved medications, representing 2 different classes of medicines, there remains a need for new treatment options for fibromyalgia patients,” Gregory Sullivan, MD, Chief Medical Officer, Tonix Pharmaceuticals, added.¹ “If approved by FDA, TNX-102 SL would be the first of a new tricyclic class of medicines for treating fibromyalgia. The existing FDA-approved drugs for fibromyalgia include the gabapentinoid class, represented by Pfizer’s Lyrica® (pregabalin) approved in 2008, and the SNRI class, represented by Lilly’s Cymbalta® (duloxetine) and AbbVie’s Savella® (milnacipran) approved in 2007 and 2009, respectively. The TNX-102 SL tablet is based on a proprietary eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and efficiently delivers cyclobenzaprine by the transmucosal route into the bloodstream. I would like to thank all the participants in our clinical trials, as well as the trial investigators and staff, who worked together over many years to help make this important milestone possible.”

REFERENCES

1. Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA). News release. Tonix Pharmaceuticals. October 16, 2024. https://globenewswire.com/en/news-release/2024/10/16/2963986/28908/en/Tonix-Pharmaceuticals-Announces-Submission-of-the-TNX-102-SL-New-Drug-Application-NDA-for-Fibromyalgia-to-the-U-S-Food-and-Drug-Administration-FDA.html

2. Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the 2024 Military Health System Research Symposium (MHSRS). News release. Tonix Pharmaceuticals. August 28, 2024. https://ir.tonixpharma.com/news-events/press-releases/detail/1511/tonix-pharmaceuticals-presented-data-and-analyses-of