MYOBLOC
MYOBLOC (Botulinum Toxin Type B) is an acetylcholine release inhibitor indicated for use in adult patients. It is approved to treat cervical dystonia, specifically to reduce the severity of abnormal head position and associated neck pain. The drug is also indicated for the treatment of chronic sialorrhea. Its therapeutic role involves the targeted inhibition of cholinergic transmission in both muscular and glandular tissues.
How MYOBLOC Works
MYOBLOC blocks the release of acetylcholine from peripheral cholinergic nerve terminals at the neuromuscular and salivary neuroglandular junctions. The neurotoxin binds to and enters the nerve terminal, where its light-chain component cleaves the synaptic Vesicle Associated Membrane Protein (VAMP). Because VAMP is essential for acetylcholine release, its cleavage prevents the transmission of nerve impulses to muscles and glands. Normal transmission is eventually re-established through the formation of new nerve endings.
Details
- Status
- Prescription
- First Approved
- 2000-12-08
- Routes
- N/A
- Dosage Forms
- VIAL
MYOBLOC Approval History
What MYOBLOC Treats
2 indicationsMYOBLOC is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cervical Dystonia
- Chronic Sialorrhea
MYOBLOC Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of MYOBLOC 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 MYOBLOC 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, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia 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 MYOBLOC 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
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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.
MYOBLOC FDA Label Details
ProIndications & Usage
FDA Label (PDF)MYOBLOC is an acetylcholine release inhibitor indicated for: Treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults Treatment of chronic sialorrhea in adults 1.1 Cervical Dystonia MYOBLOC is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults. 1.2 Chronic Sialorrhea MYOBLOC is indicated for the treatment of chronic sialorrhea in adults.
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of MYOBLOC 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.