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film containing Dexmedetomidine · 1 trial · 2 indications
The change in PEC score was evaluated at 2 hours following the administration of the BXCL501 60 mcg, and BXCL501 30 mcg (for Part A) and BXCL501 40 mcg (for Part B) versus placebo. PEC is the sum of 5 subscales (poor impulse control, tension, hostility, uncooperativeness, and excitement, each subscale ranging from 1 to 7) and thus ranges from 5 to 35. Change from baseline (pre-dose) PEC total score, with negative values is in favor of improvement.
The safety and tolerability of single doses of BXCL501 was determined in treatment of acute agitation associated with dementia.
| Arm | Type | Description |
|---|---|---|
| Cohort 1- 30 Micrograms | ACTIVE_COMPARATOR | Cohort 1 consists of 10 patients out of whom 8 patients receive 30 Micrograms film and the remaining 2 patients receive a placebo |
| Cohort 2- 60 Micrograms | ACTIVE_COMPARATOR | Cohort 2 consists of 10 patients out of whom 8 patients receive 60 Micrograms film and the remaining 2 patients receive a placebo. Additional 20 subjects receive 60 Micrograms or placebo. |
| Cohort 3- 90 Micrograms | ACTIVE_COMPARATOR | Cohort 3 consists of 10 patients out of whom 8 patients receive 90 Micrograms film and the remaining 2 patients receive a placebo |
| Part B Cohort | ACTIVE_COMPARATOR | Part B cohort consists 46 subjects receiving 40 Micrograms or placebo |
| Name | Type | Description |
|---|---|---|
| Sublingual film containing Dexmedetomidine | DRUG | Sublingual film containing Dexmedetomidine |
| Sublingual Placebo Film | DRUG | Sublingual placebo film that matches BXCL501 |
Inclusion Criteria: * Male and female patients 65 years and older. * Patients who have dementia and a history of acute agitation. * History of agitation that requires intervention or impairs social or daily activities * Patients who meet International Psychogeriatric Association (IPA) diagnostic cr...
The Dexmedetomidine film is being developed for the treatment of agitation and psychomotor agitation, particularly in the context of dementia. It is an investigational small molecule designed for sublingual administration. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BioXcel Therapeutics, Inc. (NASDAQ: BTAI) is developing the Dexmedetomidine film. The company is conducting clinical trials to evaluate the drug's safety and efficacy for managing agitation associated with dementia. The drug is in Phase 1 development, and no regulatory approval has been granted yet.
The Dexmedetomidine film is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 trial has been completed, and the drug remains in early-stage development for the treatment of agitation and psychomotor agitation in dementia patients.
The Dexmedetomidine film has one completed Phase 1 trial, NCT04251910, titled 'Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia.' This randomized, double-blind, active-controlled study enrolled 100 participants aged 65 years and older in the United States. The trial evaluated the drug for agitation and psychomotor agitation in dementia.
The Dexmedetomidine film contains dexmedetomidine as its active pharmaceutical ingredient. Dexmedetomidine is a well-known sedative agent, but this specific film formulation is being developed by BioXcel Therapeutics for agitation in dementia. The film is an investigational product and is not the same as approved intravenous dexmedetomidine formulations.