Tonix submits NDA for non-narcotic fibromyalgia pain relief

The biopharmaceutical company submitted a new drug application (NDA) to the FDA in October for TNX 102 SL (cyclobenzaprine HCl sublingual tablets), Tonix's drug candidate for the management of fibromyalgia.

Tonix expects to hear a decision on NDA acceptance by the FDA in mid-December. If the NDA is accepted, Tonix said the FDA could commit to a decision on approval in 2025, which means TNX 102 SL could be on the market as early as next year, giving fibromyalgia sufferers a much-needed new non-opioid option. As it stands, Tonix believes 85% of fibromyalgia patients fail their first-line therapy, and 79% are on multiple therapies.

With TNX 102 SL treatment, patients in Tonix's studies experienced less pain, the company says. In the most recent phase III trial, called RESILIENT, TNX 102 SL showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that in the RESILIENT study, significant results were also seen in improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. TNX 102 SL was generally well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablets under the tongue.

If the FDA approves TNX 102 SL for fibromyalgia, it could pave the way for the drug to become a first line therapy for fibromyalgia. Fibromyalgia is now recognized as the prototypic nociplastic pain disorder. Nociplastic pain, also known as central sensitization is a type of pain that occurs when the brain processes sensory signals in an altered way, which amplifies how they are perceived. This amplification of sensory information is believed to result in the pain that fibromyalgia patients experience.