DYSPORT
DYSPORT (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent used for both therapeutic and aesthetic purposes. It is indicated for the treatment of cervical dystonia in adults and spasticity in pediatric and adult patients aged two years and older. Additionally, it is approved for the temporary improvement of moderate to severe glabellar lines in adults under the age of 65. The drug is utilized to manage conditions characterized by excessive efferent activity in the motor nerves.
How DYSPORT Works
This agent works by preventing the release of the neurotransmitter acetylcholine from peripheral cholinergic nerve endings. The toxin binds to specific surface receptors on nerve endings and is internalized, where it cleaves the SNAP25 protein to block the exocytosis of neurotransmitters into the neuromuscular junction. This process results in a localized reduction of muscle activity. Neuromuscular transmission gradually recovers as the junction repairs the cleaved proteins and new nerve endings are established.
Details
- Status
- Prescription
- First Approved
- 2009-04-29
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DYSPORT Approval History
What DYSPORT Treats
3 indicationsDYSPORT is approved for 3 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cervical dystonia in adults
- Moderate to severe glabellar lines in adults less than 65 years of age
- Spasticity in patients 2 years of age and older
DYSPORT Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of DYSPORT 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, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties ...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of DYSPORT 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, blurred vision, 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 underlying conditions that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose [ see Warnings and Precautions (5.1) ]. WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning The effects of DYSPORT 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 occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. ( 5.1 )
Active Pipeline
Ongoing clinical trials by development phase
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.
DYSPORT FDA Label Details
ProIndications & Usage
FDA Label (PDF)DYSPORT is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for: the treatment of cervical dystonia in adults the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults < 65 years of age The treatment of spasticity in patients 2 years of age and older 1.1 Cervical Dystonia DYSPORT is indicated for the treatment of cervical dystonia in adults. 1.2 Glabellar Lines DYSPORT is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of DYSPORT 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, bl...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.