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Nuceiva (BOTULINUM TOXIN TYPE A)
Nuceiva works by blocking the release of acetylcholine, a neurotransmitter that transmits signals from nerve cells to muscles, thereby reducing muscle spasms and contractions.
At a glance
| Generic name | BOTULINUM TOXIN TYPE A |
|---|---|
| Sponsor | GlaxoSmithKline K.K. |
| Drug class | Acetylcholine Release Inhibitor [EPC] |
| Target | Synaptosomal-associated protein 25 |
| Modality | Recombinant protein |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2019 |
Mechanism of action
XEOMIN blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of SNAP25, presynaptic target protein essential for the release of acetylcholine. In both muscles and glands, impulse transmission is re-established by the formation of new nerve endings.
Approved indications
- Lower limb spasticity
- Neurogenic bladder
- Overactive bladder
- Rhytidectomy of glabellar frown lines
- Upper limb spasticity
- Urge urinary incontinence
- Urinary frequency
Boxed warnings
- WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including DAXXIFY, 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, an unapproved use for DAXXIFY, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms [see Warnings and Precautions (5.1) ]. WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of DAXXIFY 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, an unapproved use for DAXXIFY, 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 )
Common side effects
- Muscular weakness
- Dysphagia
- Musculoskeletal pain
- Injection site discomfort
- Fatigue
- Headache
- Dry mouth
- Injection site pain
- Eye disorders
- Dysphonia
- Falls
- Pain in extremity
Key clinical trials
- DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia (PHASE1,PHASE2)
- Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome (PHASE2)
- A Study to Evaluate Patient Satisfaction With the Overall Face and Neck Appearance After Combined Treatment of OnabotulinumtoxinA, JUVÉDERM® Products, KYBELLA, CoolSculpting Elite and SkinMedica Products (PHASE4)
- DaxibotulinumtoxinA for Blepharospasm (PHASE2)
- Prospective, Non-interventional Study Assessing Periorbital Rejuvenation Procedure
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine (PHASE3)
- A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine (PHASE3)
- Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |