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XPF-001 · 2 trials · 3 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 | - |
| 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...
XPF-001 is an investigational small molecule being developed by Xenon Pharmaceuticals Inc. (ticker XENE) as a treatment for pain. It has been studied in dental pain following wisdom tooth extraction and in primary erythromelalgia, a rare inherited pain condition. XPF-001 is in Phase 2 clinical development.
XPF-001 is being studied for the treatment of dental pain following wisdom tooth extraction and for primary erythromelalgia, also called inherited erythromelalgia. Both are pain indications. The drug remains investigational and has not been approved for any use.
XPF-001 is being developed by Xenon Pharmaceuticals Inc., which trades on the Nasdaq under the ticker symbol XENE. Xenon is the sponsor of the clinical trials evaluating XPF-001 in pain indications.
XPF-001 is in Phase 2 clinical development. A completed Phase 2 trial evaluated the drug for pain following wisdom tooth extraction, and a completed Phase 1 trial studied it in primary erythromelalgia. XPF-001 is investigational and has not been approved by the FDA.
XPF-001 has been studied in two completed trials. NCT00954356 was a Phase 2, randomized, double-blind, placebo-controlled study of XPF-001 for pain after wisdom tooth extraction, enrolling 61 participants in the United States. NCT01090622 was a Phase 1 study in primary erythromelalgia that enrolled 4 participants in the Netherlands.
The Phase 2 dental pain trial, NCT00954356, was a randomized, double-blind, placebo-controlled study that enrolled 61 participants, including healthy volunteers, in the United States. Participants were 18 years or older. The trial evaluated XPF-001 for pain following wisdom tooth extraction and has been completed.