Tonix Pharmaceuticals (TNXP) presents a potential breakthrough in fibromyalgia treatment, targeting the estimated four million American adults suffering from its debilitating effects.
The company’s candidate drug TNX-102 SL* has completed a successful second phase 3 clinical trial. This drug targets poor sleep quality, a core pathology of fibromyalgia that prevents affected patients from getting restorative sleep.
Traditional sleeping pills may impair sleep quality, while TNX-102 SL facilitates restorative sleep. This led to successful efficacy and tolerability outcomes in two phase 3 trials, showing improvements in sleep quality and daily pain reduction.
The company plans to file for marketing approval with the FDA in the second half of this year, marking a potential turning point for fibromyalgia patients.
Dr. Seth Lederman, CEO of Tonix, emphasizes the impact of TNX-102 SL beyond sleep and pain, noting improvements in fatigue, symptoms, and better function for patients. Furthermore, the latest study shows improvements in sexual function in women.
Positive Trial Results
The latest phase 3 trial in fibromyalgia demonstrated significant improvements in sleep quality and daily pain reduction, offering hope to patients who have long suffered from the condition. If approved by the FDA, TNX-102 SL would be the first new drug approved for fibromyalgia in over a decade, as well as the first member of a new class of drugs for the condition, offering a pioneering new mechanism of action relative to the three approved medications.
The drug’s ability to reduce pain, coupled with its favorable side effects profile, may address the unmet needs in fibromyalgia treatment, providing a first-line medicine suitable for long-term use in managing the condition.
Tonix’s RESILIENT phase 3 trial and the earlier RELIEF trial, completed in 2020, position the company to submit a New Drug Application (NDA) to the FDA under the 505(b)(2) regulatory approval pathway, with plans to do so in the second half of 2024.
Addressing Unmet Needs
The available FDA-approved drugs for fibromyalgia, including Cymbalta, Lyrica, and Savella, have limitations, often causing side effects and lacking improvements in both sleep and fatigue. Dissatisfaction with current medicines has led to the development of newer treatments.
Despite the shortcomings of existing medications, Cymbalta and Lyrica, both now off patent, enjoyed combined annual peak sales of approximately $10 billion. The unmet treatment needs in fibromyalgia prompt patients to switch frequently between approved drugs and resort to off-label drugs, home remedies, and addictive opioids.
Dr. Lederman underscores that TNX-102 SL has the potential to offer long-term relief to fibromyalgia patients, boosting adherence to prescribed medicines and improving outcomes.
The company’s plans to file for FDA approval are anticipated to have a significant impact on the fibromyalgia treatment landscape, potentially offering a ray of hope to millions of individuals afflicted by the condition.