Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BXCL501 · 3 trials · 10 indications
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
To assess the safety of 120 mcg BXCL501 when used in an at-home environment based on serious adverse events (SAE) and treatment emergent adverse events (TEAEs).
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Establish the safety of BXCL501 relative to placebo and lofexidine in subjects with OUD who are physically dependent on opioids as measured by the frequency of adverse events.
| Arm | Type | Description |
|---|---|---|
| Part 1: 60 mcg of BXCL501 | EXPERIMENTAL | Sublingual film containing 60 Micrograms Dexmedetomidine |
| Part 1: Matching Placebo | PLACEBO_COMPARATOR | Sublingual Placebo film |
| Part 2: 120 mcg of BXCL501 | EXPERIMENTAL | Sublingual film containing 120 Micrograms Dexmedetomidine |
| Part 2: Matching Placebo | PLACEBO_COMPARATOR | Sublingual Placebo film |
| Cohort 1- 40 Micrograms | EXPERIMENTAL | Sublingual film containing 40 Micrograms Dexmedetomidine |
| Cohort 2- 60 Micrograms | EXPERIMENTAL | Sublingual film containing 60 Micrograms Dexmedetomidine |
| Placebo | PLACEBO_COMPARATOR | Sublingual Placebo film |
| BXCL501 (180 micrograms) | EXPERIMENTAL | The current study is a randomized, double-blind, double-dummy inpatient study comparing BXCL501 (180 and 240 ug BID), lofexidine (as a positive control), and placebo. |
| BXCL501 (240 micrograms) | EXPERIMENTAL | The current study is a randomized, double-blind, double-dummy inpatient study comparing BXCL501 (180 and 240 ug BID), lofexidine (as a positive control), and placebo. |
| Lofexidine (Positive Control) | ACTIVE_COMPARATOR | The current study is a randomized, double-blind, double-dummy inpatient study comparing BXCL501 (180 and 240 ug BID), lofexidine (as a positive control), and placebo. |
| Name | Type | Description |
|---|---|---|
| BXCL501 | DRUG | Sublingual Film |
| Matching Placebo | DRUG | Sublingual Placebo Film |
| BXCL501 (180 micrograms) | DRUG | Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design. |
| BXCL501 (240 micrograms) | DRUG | Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design. |
| Placebo | OTHER | Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design. |
| Lofexidine (Positive Control) | OTHER | Throughout the 7-day inpatient study (Figure 1; Table 1), participants will receive sublingual BXCL501 or placebo twice daily and lofexidine or placebo 4 times daily using a double-blind, double-dummy design. |
A patient may enroll in only one part of the study; either Part 1 or Part 2. Inclusion Criteria: * Male and female patients between the ages of 18 to 75 years, inclusive * Patients who can read, understand and provide written informed consent. * Patients who have met Diagnostic and Statistical Man...