Two positive Phase 3 studies completed — expect to file NDA in 2nd Half 2024
Phase II start — PREVAIL study enrollment complete
TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique patented formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. TNX-102 SL is a centrally acting analgesic that helps in relieving pain by improving sleep.
Two key highlights of TNX-102 SL are:
- Rapid transmucosal absorption into the blood, a desired feature for administration at bedtime, when a more rapid onset of action is believed to be beneficial.
- Avoidance of first-pass hepatic metabolism, and reduction of the formation of the long-lived active metabolite, norcyclobenzaprine (nCBP) which is associated with unfavorable side effects.
As a multifunctional agent with potent binding and antagonist activities at the serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development and has active IND’s as a daily bedtime treatment for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer’s disease (AAD). TNX-102 SL for AAD has been designated by the FDA a Fast Track development program. Tonix is also pursuing the indication of Long Covid or PASC (post-acute sequelae of COVID-19) using TNX-102 SL.
TNX-102 SL is covered by a number of issued and pending worldwide patents which cover composition of matter related to the eutectic technology and sublingual formulation. These patents are owned outright by Tonix Pharmaceuticals, and no obligations are owed to another party. U.S. protection is expected until 2035.