Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XPF-001 · 3 trials · 4 indications
The primary efficacy variable was total pain relief at the 6-hour observation (TOTPAR 6); TOTPAR 6 is an area calculation incorporating time and relief scores over the 6 hours following dosing and was calculated using Simpson's trapezoidal rule. The higher the LS Means scores, the more pain relief was obtained. Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 6 score = 0, maximum possible score = 24
| Arm | Type | Description |
|---|---|---|
| XPF-001 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Matching Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1: Single dose of XPF-001 | EXPERIMENTAL | - |
| Cohort 2: Single dose of XPF-001 | EXPERIMENTAL | - |
| Cohort 3: Single dose of XPF-001 | EXPERIMENTAL | - |
| Cohort 4: Single dose of XPF-001 | EXPERIMENTAL | - |
| Cohort 5: Single dose of XPF-001 | EXPERIMENTAL | - |
| Cohort A: Repeated doses of XPF-001 | EXPERIMENTAL | - |
| Cohort B: Repeated doses of XPF-001 | EXPERIMENTAL | - |
| Cohort C: Repeated doses of XPF-001 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| XPF-001 | DRUG | Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules) |
| placebo | DRUG | Single oral administration of 5 x 100 mg Placebo capsules. |
Inclusion Criteria: * Males (aged 18-60) and females of non-childbearing potential (aged 18-60; * BMI between 19.5 to 32.0 kg/m2; * Outpatient, scheduled to undergo surgical extraction of 2 or more impacted 3rd molars (with at least 1 partial bony mandibular extraction); * use of only the following...