Pharma Focus America

Tonix Pharmaceuticals Completes Patient Enrollment for Phase 3 RESILIENT Trial Evaluating TNX-102 SL in Fibromyalgia Management, Paving the Way for Potential NDA Submission

Wednesday, August 02, 2023

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the completion of patient enrollment in its potentially final Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCL sublingual tablets) 5.6 mg for fibromyalgia management. The trial included 457 participants and is expected to yield topline data in the next quarter. TNX-102 SL is being developed as a non-opioid, centrally acting analgesic intended for daily bedtime use to manage fibromyalgia. If successful, the trial could fulfill the requirements for a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).

Dr. Seth Lederman, Chief Executive Officer of Tonix, emphasized the significance of this milestone for both the company and the fibromyalgia community. The current treatments for fibromyalgia have not fully met patients' needs, and there has been no new FDA-approved therapy for the condition since 2009. TNX-102 SL holds promise as a new non-addictive, non-opioid medication that provides comprehensive symptom coverage and can be used on a chronic basis for fibromyalgia management. With all other necessary requirements for an NDA already fulfilled, Tonix looks forward to the upcoming data readout and an expedited NDA submission.

Previously, in December 2020, Tonix reported positive results from the first Phase 3 study (RELIEF) of TNX-102 SL 5.6 mg for fibromyalgia management. The drug met its primary endpoint, significantly reducing daily pain compared to placebo in participants with fibromyalgia. It also showed higher responder rates and demonstrated improvements in sleep quality, fatigue mitigation, and fibromyalgia-specific global symptomatic and functional recovery. TNX-102 SL was generally safe and well-tolerated, with a similar adverse event profile to previous fibromyalgia studies.

The Phase 3 RESILIENT trial is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of TNX-102 SL in fibromyalgia management. Participants were randomized into two groups, receiving either TNX-102 SL 5.6 mg or placebo tablets. The primary endpoint is the change in daily diary pain severity score from baseline to Week 14, analyzed using mixed model repeated measures with multiple imputation.

Fibromyalgia is a chronic pain disorder believed to arise from amplified sensory and pain signaling in the central nervous system. It affects around 6-12 million adults in the U.S., with women constituting approximately 90% of those impacted. Common symptoms include widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Patients may also experience cognitive dysfunction and mood disturbances like anxiety and depression. Fibromyalgia can severely impede daily activities, reduce overall quality of life, and often lead to disability. Existing treatments have left both physicians and patients dissatisfied.

TNX-102 SL is a patented sublingual tablet formulation containing cyclobenzaprine hydrochloride, designed for rapid transmucosal absorption and reduced production of the long half-life active metabolite, norcyclobenzaprine. By avoiding first-pass hepatic metabolism, TNX-102 SL acts as a multifunctional agent, binding and antagonizing receptors such as 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. Tonix Pharmaceuticals is developing TNX-102 SL as a daily bedtime treatment for fibromyalgia, Long COVID (post-acute sequelae of COVID-19 [PASC]), alcohol use disorder, and agitation in Alzheimer's disease. Various patents, including United States Patent No. 9636408, Patent No. 9956188, Patent No. 10117936, Patent No. 10,357,465, and Patent No. 10736859, have been issued by the United States Patent and Trademark Office (USPTO) to protect the proprietary TNX-102 SL composition, which includes the Protectic™ protective eutectic and Angstro-Technology™ formulation.

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