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onabotulinumtoxinA 44 U · 1 trial · 3 indications
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. The percentage of participants with a score of none or mild at Day 30 is reported.
| Arm | Type | Description |
|---|---|---|
| onabotulinumtoxinA 24U | OTHER | 24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| placebo (normal saline) | PLACEBO_COMPARATOR | Normal Saline (placebo) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| onabotulinumtoxinA 44U | EXPERIMENTAL | 44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| Name | Type | Description |
|---|---|---|
| normal saline | DRUG | Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. |
| 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 may receive up to 2 treatments during the study. |
| 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 may receive up to 2 treatments during the study. |
Inclusion Criteria: * Successfully completed Study 191622-099 Exclusion Criteria: * Known immunization or hypersensitivity to botulinum toxin of any serotype * Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment) * Diagnosis of myasthen...
OnabotulinumtoxinA 44 U is used for the treatment of facial rhytides, specifically crow's feet lines and glabellar lines. It is a botulinum toxin type A product being developed by AbbVie Inc. for dermatological use in reducing the appearance of these facial wrinkles.
OnabotulinumtoxinA 44 U is a botulinum toxin type A that works by temporarily blocking the release of acetylcholine at the neuromuscular junction, which prevents muscle contractions that cause dynamic wrinkles. This relaxes the facial muscles, smoothing crow's feet and frown lines.
OnabotulinumtoxinA 44 U is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate its safety and efficacy for treating facial rhytides.
OnabotulinumtoxinA 44 U is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the data will support potential regulatory submissions.
OnabotulinumtoxinA 44 U has one completed Phase 3 trial, NCT01224015, which evaluated its safety and efficacy for crow's feet lines and frown lines. The trial enrolled 684 participants across the United States, Canada, France, and Germany, and was randomized, double-blind, and placebo-controlled.
OnabotulinumtoxinA 44 U is a specific dose formulation of botulinum toxin type A, which is the same active ingredient used in Botox. However, it is being studied as a distinct product for facial rhytides, and its development and approval status are separate from Botox.