Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DAXI 80 U · 1 trial · 1 indication
Change from baseline in the Numeric Pain Rating Scale (NPRS) score, which is recorded within 15 minutes after stepping out of bed in the morning and averaged over 5 days (defined as 4 days prior to study visit and on the study visit day), at Week 8. The outcome was measured by an 11-point scale scored from 0-10 where 0 is no pain and 10 is the worst pain imaginable.
| Arm | Type | Description |
|---|---|---|
| DAXI 80 U | EXPERIMENTAL | LOW Dose Group |
| DAXI 120 U | EXPERIMENTAL | HIGH Dose Group |
| Placebo | PLACEBO_COMPARATOR | Placebo Group. |
| Name | Type | Description |
|---|---|---|
| DAXI 80 U | BIOLOGICAL | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group) |
| DAXI 120 U | BIOLOGICAL | DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group) |
| Placebo | OTHER | Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution. |
Inclusion Criteria: * Written informed consent, including authorization to release health information. * Male or female subjects 18 to 65 years of age with diagnosis of unilateral plantar fasciitis. * Persistent heel pain. * Women of child bearing potential must have a negative pregnancy test at Sc...
DAXI 80 U is an investigational monoclonal antibody being developed for the treatment of plantar fasciitis, a musculoskeletal condition causing heel pain. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
DAXI 80 U is being developed by Revance Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RVNC. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment for plantar fasciitis.
DAXI 80 U is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 2 trial for plantar fasciitis has been completed.
DAXI 80 U has one completed Phase 2 clinical trial, identified as NCT03825315, titled 'DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis.' This randomized, double-blind, placebo-controlled study enrolled 155 participants in the United States.
DAXI 80 U is a formulation of daxibotulinumtoxinA for injection, as indicated by the clinical trial title. The investigational drug is being studied specifically for plantar fasciitis, and the trial NCT03825315 evaluates this treatment in a placebo-controlled setting.