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onabotulinumtoxinA 24 U · 1 trial · 3 indications
The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.
| Arm | Type | Description |
|---|---|---|
| onabotulinumtoxinA 44U | EXPERIMENTAL | 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| onabotulinumtoxinA 24U | OTHER | 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| placebo (normal saline) | PLACEBO_COMPARATOR | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. |
| Name | Type | Description |
|---|---|---|
| onabotulinumtoxinA 24 U | BIOLOGICAL | 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart. |
| onabotulinumtoxinA 44 U | BIOLOGICAL | 44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart |
| normal saline | DRUG | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart. |
Inclusion Criteria: * Moderate to severe Crow's Feet Lines and Frown Lines * Have adequate vision without the use of eyeglasses to assess facial wrinkles in the mirror (contact lenses OK) Exclusion Criteria: * Current or previous botulinum toxin treatment of any serotype * Diagnosis of myasthenia...
OnabotulinumtoxinA 24 U is used for facial rhytides, specifically crow's feet lines and glabellar lines. It is being developed by AbbVie Inc. for the treatment of these facial wrinkles. The drug is currently in Phase 3 clinical development and is considered investigational.
OnabotulinumtoxinA 24 U is a monoclonal antibody that targets the neuromuscular junction. It works by blocking the release of acetylcholine, which temporarily relaxes the muscles that cause facial wrinkles. This mechanism reduces the appearance of crow's feet lines and glabellar lines.
AbbVie Inc. (NYSE: ABBV) is developing onabotulinumtoxinA 24 U. The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating facial rhytides, including crow's feet lines and glabellar lines.
OnabotulinumtoxinA 24 U is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is not yet available for commercial use.
OnabotulinumtoxinA 24 U has one completed Phase 3 trial, NCT01189760, which evaluated its safety and efficacy for crow's feet lines and frown lines. The trial enrolled 917 participants and was randomized, double-blind, and placebo-controlled. It was conducted in the United States, Canada, France, and Germany.
OnabotulinumtoxinA 24 U is a specific dose formulation of botulinum toxin type A, which is the active ingredient in Botox. However, it is being studied as a distinct product for facial rhytides. The drug is not yet approved and is in Phase 3 clinical trials.