Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sublingual film containing Dexmedetomidine, Sublingual film containing Dexmedetomidine (BXCL501)
film containing Dexmedetomidine · 3 trials · 9 indications
The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).
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 |
|---|---|---|
| 120 Micrograms | EXPERIMENTAL | Sublingual film containing 120 Micrograms Dexmedetomidine |
| 180 Micrograms | EXPERIMENTAL | Sublingual film containing 180 Micrograms Dexmedetomidine |
| Placebo | PLACEBO_COMPARATOR | Sublingual placebo film |
| 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 (BXCL501) | DRUG | Sublingual film containing Dexmedetomidine (BXCL501) |
| Placebo Film | DRUG | Placebo Film for BXCL501 |
| Sublingual film containing Dexmedetomidine | DRUG | Sublingual film containing Dexmedetomidine |
| Sublingual Placebo Film | DRUG | Sublingual placebo film that matches BXCL501 |
Inclusion Criteria: 1. Male and female patients between the ages of 18 to 75 years, inclusive. 2. Patients who have met DSM-5 criteria for bipolar I or II disorder. 3. Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse...
The sublingual film containing dexmedetomidine, also known as BXCL501, is an investigational small-molecule product developed by BioXcel Therapeutics for agitation. It is formulated as a film placed under the tongue and is being studied in agitation associated with bipolar disorder, schizophrenia, and dementia. It is in Phase 3 development.
The sublingual film containing dexmedetomidine is being developed to treat agitation, including agitation associated with bipolar disorder and psychomotor agitation. Phase 3 trials have enrolled adults with agitation associated with bipolar disorder and schizophrenia, and an earlier Phase 1/Phase 2 study enrolled older adults with agitation associated with dementia.
BioXcel Therapeutics, Inc. is developing the sublingual film containing dexmedetomidine, which is also referred to as BXCL501. The company trades under the ticker BTAIQ. The asset is a small-molecule product in the psychiatry therapeutic area, formulated as a sublingual film for agitation.
The sublingual film containing dexmedetomidine is in Phase 3 development. It is investigational and has been studied in completed Phase 3 trials in agitation associated with bipolar disorder and schizophrenia, plus a completed Phase 1/Phase 2 trial in agitation associated with dementia. It is not described as approved.
Three completed trials are registered for the sublingual film containing dexmedetomidine. NCT04276883 was a Phase 3 trial in agitation associated with bipolar disorder with 380 participants. NCT04268303 was a Phase 3 trial in agitation associated with schizophrenia, also with 380 participants. NCT04251910 was a Phase 1/Phase 2 trial in agitation associated with dementia with 100 participants.
Yes. BXCL501 is another name for the sublingual film containing dexmedetomidine. The product is also referred to as sublingual film containing dexmedetomidine (BXCL501). All of these names refer to the same investigational BioXcel Therapeutics asset being developed for agitation.