The U.S. Food and Drug Administration (FDA) approved Tonix Pharmaceuticals’ investigational new drug (IND) application to support the start of a Phase 2 trial of TNX-102 SL in Alzheimer’s patients with agitation. In December 2016, the treatment candidate was granted breakthrough therapy status — a process designated to accelerate the development of promising medications for serious conditions — for the treatment of post-traumatic stress disorder (PTSD). The investigational medication has a conditionally accepted name of Tomnya for PTSD and is currently in Phase 3 development for that condition. Similar to PTSD, Tonix is testing TNX-102 SL for Alzheimer’s patients at a 5.6 mg dose. The medication is being developed as an under-the-tongue tablet and was designed to act on diverse neurotransmitter pathways related to common sleep disturbances, as it blocks receptors of:

• serotonin (associated with an increase in restorative slow wave sleep and a decrease in waking-after-sleep-onset);
• adrenergic (associated with reducing trauma-related nightmares and sleep disturbance), and;
• histamine (associated with the reversal of stress-induced increases in rapid eye movement sleep).

“This potential new indication for TNX-102 SL expands our clinical development pipeline, leveraging our understanding of the TNX-102