FDA Clearance Supports Start of Phase 2 Trial of TNX-102 SL for Agitation in Alzheimer’s Patients

FDA Clearance Supports Start of Phase 2 Trial of TNX-102 SL for Agitation in Alzheimer’s Patients
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 SL mechanism of action on sleep quality and our understanding of its potential clinical benefit in patients with agitation in Alzheimer’s,” Seth Lederman, MD, president and CEO, said in a press release. Lederman said that TNX-102 SL may become a new therapy for Alzheimer’s patients with agitation, a patient population lacking FDA-approved treatments. He also said that Tonix will file a fast track application next month aiming to speed u
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