Tonix Pharmaceuticals Holding Corp. announced it is filing an NDA submission in second half of this year and has completed both manufacturing and multi-disciplinary-focused pre-NDA meetings with FDA. As the anticipated NDA filing and FDA approval dates for the commercial launch of Tonmya?

for the management of fibromyalgia, assuming approval by the FDA in 2H 2025. The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now with two drugs making their way through the FDA - Tonix's Tonmya and one from another U.S. company - there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created $10 billion in peak sales.

According to an opportunity analysis commissioned by Tonix and carried out by Eversana for Tonix's drug, Tonmya?, fibromyalgia affects around 2.7 million diagnosed and treated patients in the United States. Despite the high prevalence of this condition, the treatment landscape has remained largely stagnant for over 15 years. Tonix will be competing for a slice of a global market that was valued at over $3 billion in 2023 and is expected to grow at a compound annual growth rate of 3.8% from 2024 to 2030.

Tonix Enters the Ring with Tonmya: Tonmya is a new therapeutic class and unlike the three currently approved fibromyalgia drugs, which are involved in the uptake of both serotonin and norepinephrine or are more specific for norepinephrine than serotonin. The other new drug candidate heading for FDA approval is very specific for norepinephrine and does not affect serotonin. Tonmya (also known as TNX-102 SL) is a non-opioid, non-addictive sublingual tablet designed for bedtime use.

Tonmya is a sublingual formulation of cyclobenzaprine hydrochloride, which has improved sleep quality in clinical studies. In the latest Phase 3 trial, Tonmya showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that statistically significant results were also seen in improving sleep quality, reducing depression and fatigue and improving overall fibromyalgia symptoms and function.

Tonmya was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the integration of the tablets under the tongue. Tonmya has been conditionally accepted by FDA as a trade name for the management of fibromy fibromyalgia. Tonix says it will file a new drug application (NDA) with the FDA in the second half of this year and have completed both manufacturing and multi-ciplinary-focused pre-NDA meeting with FDA.

As the anticipatedNDA filing and FDA approval date for Tonmya and a second new drug draw near, a battle in the fibromyalgia market heats up. Tonix Pharmaceuticals, with its innovative approach and promising clinical trial results, could be well positioned to disrupt a market long dominated by a few large players.