Tonix Pharmaceuticals Holding Corp ( TNXP ) shares are trading lower Tuesday after initially jumping after the company announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for TNX-102 SL, a 5.6 mg non-opioid. Here’s what you need to know.

What To Know: The FDA’s acceptance of the NDA triggers a process in which the agency will assign a Prescription Drug User Fee Act (PDUFA) target action date and determine if the application qualifies for priority review, which will be communicated in the Day 74 Letter. TNX-102 SL was granted Fast Track designation by the FDA in July 2024.

Fibromyalgia affects more than 10 million adults in the United States, with the majority being women. TNX-102 SL, if approved, could be the first new drug for treating fibromyalgia in over 15 years and the first member of a new class of analgesic drugs for the condition.

The NDA submission is supported by two Phase 3 studies — RELIEF and RESILIENT — that evaluated TNX-102 SL’s safety and efficacy. Both trials met their primary endpoints, demonstrating a statistical reduction in daily pain compared to placebo.

In the RELIEF study completed in December 2020, results showed significance with a p-value of 0.010. In the confirmatory RESILIENT trial completed in December 2023, significance was observed with a p-value of 0.00005. TNX-102 SL was generally well tolerated in both trials. The most common treatment-related adverse event was temporary numbness of the tongue or mouth at the administration site, which did not lead to significant study discontinuations.

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Tonix Pharmaceuticals’ CEO Seth Lederman noted that the fibromyalgia community has been waiting for a new drug for over 15 years and emphasized that, based on U.S. insurance claims data, fibromyalgia patients are more likely to be prescribed opioids than all three current FDA-approved drugs combined within 18 months of diagnosis.

Tonix is preparing for potential approval in 2025. The company noted that it already has a commercial leadership team in place. Tonix also markets Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) for the acute treatment of migraine.

TNXP Price Action: Tonix shares were up about 25% for the session at the time of writing, but had turned negative by publication time. At last check, Tonix shares were down 7.11% at 49 cents, according to Benzinga Pro.

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