Overview
In 2002, botulinum toxin A, also known as onabotulinumtoxinA or Botox, was the first type A botulism toxin to be introduced into the market for cosmetic use. With a wide variety of applications and favourable safety profile, Botulinum toxin A injection is a minimally invasive and promising treatment for cosmetic imperfections, muscle spasms, and other conditions. A popular use for Botox is the treatment of facial wrinkles and lines, however, there are many uses for the botulinum toxin A in the treatment of dystonia, incontinence, migraine, blepharospasm, and hyperhidrosis.
Indication
Botulinum toxin A is indicated for a variety of conditions, depending on the preparations. Cosmetically, it is used for the treatment of facial fine lines and wrinkles, specifically for upper facial rhytides, including forehead, lateral canthus, and glabellar lines. In addition to the above indications, botulinum toxin A is used for the following conditions: treatment of adults with symptomatic overactive bladder with or without incontinence, treatment of incontinence in adult patients who are not candidates for anticholinergic therapy, treatment of Neurogenic Detrusor Overactivity (NDO) in patients over 5 years who cannot undergo anticholinergic therapy. Botulinum toxin A is indicated for the prevention of chronic migraines, for the treatment of muscle spasms, cervical dystonia, axillary hyperhidrosis, strabismus, and disorders of the 7th cranial nerve. Off-label, botulinum toxin A is used for a variety of conditions such as temporomandibular joint (TMJ) disorders and myofascial pain, neurogenic thoracic outlet syndrome, epicondylitis, post-stroke pain, post-herpetic neuralgia, diabetic neuropathy, trigeminal neuralgia, neuropathic pain, spinal cord injury, and bladder pain.
Associated Conditions
- Bladder pain
- Blepharospasm
- Cervical Dystonia
- Chronic Migraine
- Diabetic Neuropathies
- Epicondylitis
- Equinus deformity of foot, acquired
- Facial Skin Wrinkles
- Glabellar Frown Lines (GL)
- Lower Limb Spasticity
- Myofascial Pain Syndrome
- Neurogenic Detrusor Overactivity
- Neurogenic Thoracic Outlet Syndrome
- Overactive Bladder Syndrome (OABS)
- Post Stroke Pain
- Postherpetic Neuralgia
- Sialorrhea
- Spasticity
- Spinal Cord Injuries
- Strabismus
- TMJ Disorders
- Trigeminal Neuralgia (TN)
- Upper Limb Spasticity
- Urinary Incontinence (UI)
- Hypertonicity disorders of the 7th nerve
- Moderate Glabellar Frown Lines (GL)
- Severe Glabellar Frown Lines (GL)
- Severe axillary hyperhidrosis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/07/12 | Phase 4 | UNKNOWN | Federal University of São Paulo | ||
2016/07/01 | Phase 3 | Completed | |||
2016/06/28 | N/A | Completed | Prof. Dr. Volker Viereck | ||
2016/06/22 | Phase 2 | UNKNOWN | |||
2016/06/01 | Phase 3 | UNKNOWN | |||
2016/05/16 | Phase 3 | Completed | |||
2016/04/25 | Phase 3 | Completed | Chang Gung Memorial Hospital | ||
2016/04/13 | Phase 2 | Terminated | |||
2016/02/09 | Phase 4 | Completed | |||
2016/02/09 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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|---|---|---|---|---|---|
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NMPA Drug Approvals
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PPB Drug Approvals
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|---|---|---|---|---|---|
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TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||
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