FDA Accepts New Drug Application for TNX-102 SL in Fibromyalgia

Tonix Pharmaceuticals announced on December 17, 2024, that the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) to treat fibromyalgia. The FDA is expected to assign the NDA a Prescription Drug User Fee Act (PDUFA) target action date in a Day 74 Letter.

“The FDA’s acceptance of our NDA represents another step forward as we pursue our goal of delivering the first member of a new class of medicines for the management of fibromyalgia, a condition affecting over 10 million adults in the US,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals, in a statement. “The fibromyalgia community, comprised of patients and their families and support groups, has been waiting for a new drug for over 15 years.”

Lederman added how an analysis of US insurance claims has shown that 18 months after a fibromyalgia diagnosis, patients were more likely to be prescribed addictive opioids than all 3 FDA-approved fibromyalgia drugs combined. Physicians and patients often report dissatisfaction with current fibromyalgia drugs on the market.

Recognizing the need for fibromyalgia treatment, the FDA granted TNX-102 SL, a 5.6 mg, non-opioid, centrally acting analgesic designed for chronic use, the Fast Track designation for fibromyalgia in July 2024. TNX-102 SL manages fibromyalgia in a non-addictive way by targeting non-restorative sleep and working as an antagonist at multiple neuroreceptor subtypes, including serotonergic, adrenergic, histaminergic, and muscarinic receptors. Tonix Pharmaceuticals is still waiting to see whether the FDA will grant the NDA a Priority Review.

The NDA submission includes data from 2 14-week double-blind, randomized, placebo-controlled phase 3 trials evaluating the safety and efficacy of TNX-102 SL as a bedtime treatment for fibromyalgia. RELIEF, the first phase 3 trial completed in December 2020, met its primary endpoint of significantly reducing daily pain compared with placebo (P = .010). The second phase 3 trial, RESILIENT, was completed in December 2023 and demonstrated a significant reduction of daily pain compared with placebo (P = .00005).

TNX-102 SL was well tolerated in both RELIEF and RESILIENT with an adverse event profile comparable to prior studies. The most common treatment-emergent adverse events were tongue or mouth numbness at the administration site, although this was never severe and rarely led to study discontinuation except for 1 participant in each trial.

Systemic adverse events in the trials, excluding COVID-19, were lower than 4%.

“We look forward to working closely with the FDA throughout the NDA review period with the goal of bringing TNX-102 SL to the market to address the significant unmet needs of the fibromyalgia community as quickly as possible,” Lederman said.

References

Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia. Globe Newswire. December 17, 2024. https://www.globenewswire.com/news-release/2024/12/17/2998199/28908/en/Tonix-Pharmaceuticals-Announces-FDA-Acceptance-of-the-New-Drug-Application-NDA-for-TNX-102-SL-for-Fibromyalgia.html. Accessed December 17, 2024.