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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Align Technology, Inc. | ALGN | 2 | N/A | Undisclosed |
| Solventum Corporation | SOLV | 1 | N/A | Undisclosed |
| Haleon PLC Sponsored ADR | HLN | 1 | N/A | Undisclosed |
| DENTSPLY SIRONA, Inc. | XRAY | 1 | N/A | Undisclosed |
| Envista Holdings Corp. | NVST | 2 | - | Undisclosed |
| Smith & Nephew plc Sponsored ADR | SNN | 1 | - | Undisclosed |
XPF-001 is an investigational small molecule being studied for the treatment of pain, including dental pain following wisdom tooth extraction and pain from primary or inherited erythromelalgia. It has also been evaluated in healthy human volunteers. The drug is in clinical development and is not approved by the FDA.
XPF-001 is being developed by Xenon Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol XENE. The company has conducted clinical trials of XPF-001 in Canada, the United States, and the Netherlands.
XPF-001 has completed Phase 1 and Phase 2 clinical trials. A Phase 2 study evaluated the drug for dental pain following wisdom tooth extraction, while Phase 1 studies assessed safety in healthy volunteers and efficacy in primary or inherited erythromelalgia. The drug remains investigational.
XPF-001 has been studied in three completed clinical trials. NCT00813670 was a Phase 1 single and multiple ascending dose study in healthy volunteers. NCT00954356 was a Phase 2 study for dental pain after wisdom tooth extraction. NCT01090622 was a Phase 1 study in patients with primary or inherited erythromelalgia.
XPF-001 is the investigational name used by Xenon Pharmaceuticals for this small molecule candidate. No alternative names have been reported in the clinical trial records. The drug is distinct from other pain medications and is being studied specifically for neuropathic and inflammatory pain conditions.