Summary: Tonix Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for TNX-102 SL, a once-daily sublingual tablet designed to improve sleep, reduce pain, and alleviate other symptoms in fibromyalgia patients. The submission is supported by positive results from two phase 3 studies showing reductions in pain and improvements in sleep quality. The FDA granted the drug Fast Track designation in the third quarter. A decision is expected in 2025.
Key Takeaways:
- NDA Submission for TNX-102 SL: Tonix seeks FDA approval for its investigational fibromyalgia treatment.
- Improved Sleep and Pain Relief: Phase 3 trials demonstrated sleep quality and pain reduction in fibromyalgia patients.
- Fast Track Designation: The FDA granted Fast Track status, expediting the review process with a decision expected in 2025.
Tonix Pharmaceuticals reported progress on its development pipeline for TNX-102 SL, a once-daily sublingual tablet targeted at improving disturbed sleep, pain, and other symptoms in fibromyalgia patients.
In October, Tonix announced the submission of the TNX-102 SL New Drug Application for fibromyalgia to the US Food and Drug Administration (FDA). The submission was based upon two phase 3 studies of TNX-102 SL, a once-daily at bedtime sublingual tablet, in fibromyalgia that showed statically significant reduction in the chronic, widespread pain associated with fibromyalgia.
If approved by the FDA, TNX-102 SL would be the first member of a new class of analgesic drugs for fibromyalgia and the first new drug available for treating fibromyalgia in more than 15 years, according to a release from the company. Fibromyalgia affects more than 10 million adults in the US, most of whom are women.
Proprietary Formulation Technology
In September 2024, at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems, the company announced data highlighting the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL, including composition and methods patents based on the eutectic formulation of TNX-102 SL that are expected to provide market exclusivity until at least 2034 in the United States, European Union, Japan, China, and other jurisdictions.
The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, improve pain, and other fibromyalgia symptoms, while reducing the risk of daytime somnolence.
Phase 3 Clinical Trials and Efficacy
In August, at both the Department of Defense’s 2024 Military Health System Research Symposium and at the International Association for the Study of Pain’s 2024 World Congress on Pain, Tonix announced additional data and analyses of TNX-102 SL for the management of fibromyalgia.
TNX-102 SL had met the pre-specified primary endpoint in the phase 3 RESILIENT study, significantly reducing daily pain compared to placebo in participants with fibromyalgia while demonstrating broad syndromal benefits with statistically significant improvement in all six pre-specified key secondary endpoints, including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals were observed.
Potential Impact on Long COVID and Next Steps
In July, Tonix noted that, based on the new definition of long COVID by the US National Academies of Sciences, Engineering, and Medicine, fibromyalgia is a “diagnosable condition” in people experiencing long COVID. The company believes that diagnosing fibromyalgia in long COVID patients will increase the potential market for TNX-102 SL following approval as compared to market estimates from before the COVID-19 pandemic.
“With our recent NDA submission to the US Food and Drug Administration, Tonix is excited about the potential of TNX-102 SL to become the first new drug treatment option in more than 15 years for the roughly 10 million adults in the US suffering from fibromyalgia,” says Seth Lederman, MD, chief executive officer of Tonix, in a release.
The FDA awarded TNX-102 SL Fast Track designation in the third quarter of 2024, which is intended to expedite FDA review of new drugs to fill unmet needs for serious conditions.
“We look forward to next steps with FDA. If the NDA filing is accepted in December, we expect a decision on the marketing approval of TNX-102 SL for fibromyalgia in 2025,” Lederman says in a release.
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