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Also known as BOTOX®
Botulinum Toxin Type A 300U · 1 trial · 1 indication
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
| Arm | Type | Description |
|---|---|---|
| Botulinum Toxin Type A 300U | EXPERIMENTAL | Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
| Botulinum Toxin Type A 200U | EXPERIMENTAL | Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
| Name | Type | Description |
|---|---|---|
| Botulinum Toxin Type A 300U | BIOLOGICAL | Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
| Botulinum Toxin Type A 200U | BIOLOGICAL | Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years. |
Inclusion Criteria: * Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled: * Patient completed at least 52 weeks in the preceding study. * No longer than 6 months has elapsed since completion of the preceding study * Patient has not received any pr...
Botulinum Toxin Type A 300U is being developed for the treatment of overactive bladder, a condition characterized by urgency, frequency, and urge incontinence. The clinical program has focused on patients whose overactive bladder results from spinal injury or multiple sclerosis, a neurogenic population with limited treatment options.
Botulinum Toxin Type A 300U targets SNAP25, a hydrolytic enzyme involved in the release of neurotransmitters from nerve terminals. By acting on SNAP25, the therapy is designed to inhibit nerve signaling that drives involuntary bladder contractions, thereby reducing overactive bladder symptoms.
Botulinum Toxin Type A 300U is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is responsible for the clinical development program in overactive bladder.
Botulinum Toxin Type A 300U is in Phase 3 clinical development for overactive bladder. The program includes a completed Phase 3 long-term follow-up study. The drug is investigational and has not been approved by the FDA for this indication.
Botulinum Toxin Type A 300U has been evaluated in a Phase 3 trial, NCT00876447, titled a long-term follow-up study in patients with overactive bladder as a result of spinal injury or multiple sclerosis. The trial enrolled 397 patients, was randomized, double-blind, and controlled, and is now completed.