BioXcel Therapeutics begins phase 3 trial for acute agitation in Alzheimer’s patients
BioXcel Therapeutics has announced that the first patient involved in the phase 3 TRANQUILITY 2 study of BXCL501 has received a dose for the acute treatment of agitation in patients with Alzheimer’s disease.
BXCL501 – the company’s orally dissolving, thin film formulation of dexmedetomidine – has been assessed as part of a pivotal phase 3 TRANQUILITY programme.
The programme began in December 2021 and is made up of two studies, TRANQUILITY 2 and TRANQUILITY 3.
Each study has been designed to evaluate the safety and effectiveness of BXCL501 in adults aged 65 years and older who are in assisted living, residential facilities or nursing homes.
Alzheimer’s disease is the most common form of dementia in the US, and it is expected that by 2040, approximately 12 million Americans aged 65 years and over may be impacted by the disease. Of these patients, up to 70% experience agitation, while around 100 million agitation episodes happen in the US annually. The knock-on effect of these episodes on both patients and their caregivers can be devastating.
As yet, there are no approved therapeutic options available for the acute treatment of agitation related to dementia, including Alzheimer’s disease.
https://www.pmlive.com/pharma_news/bioxcel_therapeutics_begins_phase_3_trial_for_acute_agitation_in_alzheimers_patients_1447890
BXCL501 – the company’s orally dissolving, thin film formulation of dexmedetomidine – has been assessed as part of a pivotal phase 3 TRANQUILITY programme.
The programme began in December 2021 and is made up of two studies, TRANQUILITY 2 and TRANQUILITY 3.
Each study has been designed to evaluate the safety and effectiveness of BXCL501 in adults aged 65 years and older who are in assisted living, residential facilities or nursing homes.
Alzheimer’s disease is the most common form of dementia in the US, and it is expected that by 2040, approximately 12 million Americans aged 65 years and over may be impacted by the disease. Of these patients, up to 70% experience agitation, while around 100 million agitation episodes happen in the US annually. The knock-on effect of these episodes on both patients and their caregivers can be devastating.
As yet, there are no approved therapeutic options available for the acute treatment of agitation related to dementia, including Alzheimer’s disease.
https://www.pmlive.com/pharma_news/bioxcel_therapeutics_begins_phase_3_trial_for_acute_agitation_in_alzheimers_patients_1447890
