Approval Probability
TA Base Rate
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ML Risk
Botulinum Toxins, Type A · 4 trials · 2 indications
Incidence rates based on the number and percentage of subjects treated within each cycle who report Adverse Events (AEs) at anytime following study treatment. Note that subjects could receive up to 3 consecutive treatments during the 36-week follow up period.
Percentage of subjects who achieve at least a 2-point improvement from baseline and a score of 0 or 1 (i.e., none or mild wrinkles in severity) on both Investigator and Subject Frown Wrinkle Severity (FWS) assessments
The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
| Arm | Type | Description |
|---|---|---|
| DaxibotulinumtoxinA 40 units | EXPERIMENTAL | Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection |
| Placebo | PLACEBO_COMPARATOR | Biological/Vaccine: Placebos Intramuscular injection |
| DAXI 240 U | EXPERIMENTAL | DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U |
| Name | Type | Description |
|---|---|---|
| Botulinum Toxins, Type A | BIOLOGICAL | Intramuscular Injection |
| Placebos | BIOLOGICAL | Intramuscular injection |
| Placebo | BIOLOGICAL | Intramuscular injection |
Inclusion Criteria: * Provide written informed consent including authorization to release health information * Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale * Moderate (2) or severe (3) glabellar li...
Botulinum toxins, type A is being developed by Revance Therapeutics for two indications: moderate to severe glabellar frown lines, the vertical lines between the eyebrows, and plantar fasciitis, a painful inflammation of the tissue along the bottom of the foot. Both programs are in clinical development.
Botulinum toxins, type A targets SNAP25, a hydrolytic enzyme protein involved in the release of neurotransmitters from nerve terminals. By acting on SNAP25, the therapy is designed to interfere with nerve signaling to the targeted muscle, which underlies its use in smoothing glabellar frown lines and in treating plantar fasciitis.
Revance Therapeutics, Inc., which trades on the Nasdaq under the ticker RVNC, is developing botulinum toxins, type A. The company is running the clinical program for the asset across dermatology and musculoskeletal indications, including glabellar frown lines and plantar fasciitis.
Botulinum toxins, type A is in Phase 3 clinical development and is investigational. It has not been established as approved. The program includes completed Phase 3 trials in glabellar frown lines and a completed Phase 2 trial in plantar fasciitis, with no trials currently listed as active.
Four completed trials are registered for botulinum toxins, type A. NCT03014635 and NCT03014622 were Phase 3 studies in moderate to severe glabellar lines, NCT03004248 was a Phase 3 safety study of single and repeat treatments in glabellar lines, and NCT03137407 was a Phase 2 study in plantar fasciitis.
Across the registered trials, total enrollment was about 3,300 participants. The glabellar line studies enrolled 306, 303, and 2,691 patients respectively, and the plantar fasciitis study enrolled 59. The trials were randomized, double blind, and placebo controlled, and enrolled adults 18 years and older.