BOTOX
BOTOX (onabotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for various neurological, muscular, and autonomic conditions in adult and pediatric patients. It is used to treat bladder dysfunctions, including overactive bladder and neurogenic detrusor overactivity, in patients who have had an inadequate response to or are intolerant of anticholinergic medications. The drug is also approved for the prophylaxis of chronic migraine in adults and the treatment of spasticity, cervical dystonia, blepharospasm, and strabismus. Additionally, it is indicated for the management of severe axillary hyperhidrosis that is inadequately managed by topical agents.
How BOTOX Works
BOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or autonomic nerve terminals and inhibiting the release of the neurotransmitter acetylcholine. This inhibition is achieved as the neurotoxin cleaves SNAP-25, a protein necessary for the successful docking and release of acetylcholine from vesicles within nerve endings. When injected into target tissues, the drug produces localized chemical denervation, resulting in a reduction of muscle activity or sweat gland production. In the bladder, the drug affects the efferent pathways of detrusor activity via this same inhibition of acetylcholine release.
Details
- Status
- Prescription
- First Approved
- 1991-12-09
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
BOTOX Approval History
What BOTOX Treats
10 indicationsBOTOX is approved for 10 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive Bladder
- Urinary Incontinence
- Detrusor Overactivity
- Neurogenic Detrusor Overactivity
- Chronic Migraine
- Spasticity
- Cervical Dystonia
- Axillary Hyperhidrosis
BOTOX Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threat...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to the se symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia an d spasticity and at lower doses [ see Warnings and Precautions ( 5.1 )] . WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms. ( 5.1 )
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BOTOX FDA Label Details
ProIndications & Usage
FDA Label (PDF)BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication Treatment of neurogenic detrusor overactivity (N...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptos...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.