Agitation is a common behavioral symptom experienced by a majority of patients with Alzheimer's Disease. It includes emotional lability, restlessness, irritability, and aggression1 and is one of the most distressing and debilitating of the behavioral complications of Alzheimer's disease. Both sleep disturbances and agitation are common and co-morbid features of Alzheimer's disease.1,2,3
The improved sleep quality seen in earlier clinical trials of TNX-102 SL for other disorders suggests TNX-102 SL could potentially be an effective treatment for agitation in Alzheimer's disease. Currently, there are no FDA-approved treatments for AAD, despite a high disease burden and a need for an effective therapy. TNX-102 SL for the treatment of AAD has been designated by the FDA a Fast Track development program, designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. It is anticipated that there will be more frequent meetings and written communication with the FDA regarding the development plan and trial design throughout the entire drug development and review process with the goal to have earlier drug approval and access by patients.
TNX-102 SL is identical to the formulation and active ingredient in Tonmya. The conditional use of the name Tonmya by the FDA has only been granted for the indication of PTSD and therefore TNX-102 SL is used to refer to all other indications under development.
Both sleep disturbances and agitation are common and co-morbid features of Alzheimer's disease.3 TNX-102 SL's mechanism of improving sleep quality may be relevant as sleep disturbance is a significant and common symptom in AAD.
A separate TNX-102 SL IND for AAD has been cleared and has sufficient data to support a Phase 2 study in patients with AAD. Tonix plans to include genomic DNA analysis to identify biomarkers that may be associated with treatment response in the Phase 2 potential pivotal efficacy study in Alzheimer’s disease patients with agitation. A final Phase 2 protocol has been submitted to the FDA for final review and acceptance.
Tonix has filed a patent for the use of TNX-102 SL for agitation, psychosis, and cognitive decline in dementia and neurodegenerative diseases (which includes Alzheimer's Disease). TNX-102 SL is also covered by a number of issued and pending worldwide patents which cover the eutectic composition of matter as well as the pharmacokinetic profile. These patents are owned outright by Tonix Pharmaceuticals and no obligations are owed to another party.
*TNX-102-SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.