Tonix Pharmaceuticals Presents Promising TNX-102 SL Data
Tonix Pharmaceuticals Showcases TNX-102 SL Data at Global Conference
The recent 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems brought together experts to discuss advancements in pharmaceutical formulations. Among these, Tonix Pharmaceuticals Holding Corp. has made notable presentations highlighting their groundbreaking candidate, TNX-102 SL, a sublingual formulation of cyclobenzaprine HCl designed for fibromyalgia treatment.
Significant Clinical Findings
In their presentations, Tonix Pharmaceuticals showcased the proprietary formulation technology and the pharmacokinetic properties of TNX-102 SL. The composition and methods patents surrounding this formulation are anticipated to secure market exclusivity through 2034 across various regions worldwide. The company plans to submit a New Drug Application (NDA) to the U.S. FDA in October 2024 and has been granted Fast Track designation for expedited review.
Positive Results from Phase 3 Studies
The Phase 3 RESILIENT study provided compelling evidence of TNX-102 SL's effectiveness, demonstrating a statistically significant improvement in managing fibromyalgia-related nociplastic pain, along with enhancements in sleep quality and overall patient well-being.
Details from Key Presentations
One of the presentations, led by Prof. Marino Nebuloni, detailed the role of mannitol as a eutectic forming agent, which is pivotal in delivering cyclobenzaprine effectively through the sublingual route. The formulation ensures a stable product that dissolves rapidly into the bloodstream, maximizing the therapeutic benefits.
Expert Commentary on the Clinical Need
Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, emphasized the unmet need for effective treatments in fibromyalgia, citing frustrations with current therapies. He noted the potential of TNX-102 SL to provide symptom relief as a once-daily treatment option, potentially marking a new era in fibromyalgia management.
Innovative Dosage Form Development
During the conference, Dr. Bruce Daugherty discussed the pharmacokinetic properties of TNX-102 SL, highlighting its design for optimal absorption and effectiveness when taken at bedtime. This careful formulation aims to alleviate disturbed sleep and reduce unwanted daytime drowsiness.
Insights from Additional Research
Also featured was Siobhan Fogarty, who presented findings on the importance of in vitro discriminatory tests in developing the TNX-102 SL tablet. These tests examine vital characteristics like dissolution and disintegration time, indicating that achieving consistent product quality is crucial for effective therapeutic outcomes.
Tonix's Commitment to Advancement
Tonix Pharmaceuticals is dedicated to elevating treatment standards for fibromyalgia and beyond, as indicated by their diverse pipeline of investigational drugs. Their recent advancements not only highlight the potential of TNX-102 SL but also demonstrate the company's proactive approach to addressing unmet medical needs.
Frequently Asked Questions
What is TNX-102 SL?
TNX-102 SL is a sublingual formulation of cyclobenzaprine HCl designed to treat fibromyalgia.
When is the NDA submission for TNX-102 SL planned?
The NDA submission is expected to occur in October 2024.
What were the results of the Phase 3 RESILIENT study?
The study showed significant improvement in managing fibromyalgia pain and enhancing sleep quality compared to a placebo.
How does TNX-102 SL differ from current fibromyalgia treatments?
TNX-102 SL aims to provide a more effective once-daily treatment option with fewer daytime side effects.
Who is presenting the research on TNX-102 SL?
Key presentations include insights from company executives and researchers, such as Prof. Marino Nebuloni and Dr. Bruce Daugherty.
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