Treatment for Alzheimer-Related Agitation Gets Fast Track Status

Currently, there are no approved treatments for behavioral symptoms (eg, aggression, agitation) in Alzheimer's disease.

Tonix announced that the Food and Drug Administration (FDA) has granted Fast Track designation to TNX-102 SL (cyclobenzaprine HCl) sublingual tablet for the treatment of agitation in Alzheimer’s disease. Currently, there are no approved treatments for this indication. 

The Company plans to evaluate the safety and efficacy of TNX-102 SL dosed at bedtime in a Phase 2 study involving patients with agitation in Alzheimer’s disease. The researchers also plan on analyzing genomic DNA to identify biomarkers associated with treatment response.

TNX-102 SL, a low-dose cyclobenzaprine HCl formulation, is thought to work by blocking the serotonin 2A receptor, the alpha-1 adrenergic receptor, and the histamine-1 receptor. Blocking these receptors may increase slow wave sleep and decrease waking-after-sleep-onset, as well as reduce trauma-related nightmares and sleep disturbance.

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TNX-102 SL was previously granted Breakthrough Therapy for the treatment of posttraumatic stress disorder (PTSD) in December 2016 and it is currently being evaluated in a Phase 3 study for military-related PTSD. 

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