12 allergies on the market for 30 years! FDA approves AbbVie botulinum toxin Botox: Treatment of neurogenic urinary muscle over-activity in children!

February 16, 2021 // -- AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has approved Botox (OnabotulinumtoxinA, BotulintoxinA, Botox A) for the treatment of ≥5-year-old pediatric patients with inadequate or insensitive anticholinergic drugs to treat bladder dystrophy (bladder muscle) associated with neuropathy.
milestone marks Botox's 12th U.S. approval for therapeutic adaptation.
noted that Botox is the first and only neurotoxin approved for the treatment of neurogenic forced urinary muscle over-activity in children.
now, there is a new treatment option for children with neurogenic forced urinary muscle over-activity who do not respond well to anticholinel drugs.
Botox selectively blocks the release of the neurotransmitter acetylcholine at the nerve muscle joint by blocking the transfer of nerve impulses to the muscles (in this case, the bladder muscles in this adaptation), temporarily reducing muscle contraction.
neurogenic urinary muscle overactive disorder occurs when the spinal cord and bladder do not communicate effectively, which may be associated with neurological disorders such as spina bifida and spinal cord injury.
result, the bladder muscles contract involuntarily, increasing the pressure in the bladder and reducing bladder capacity, which can lead to frequent and accidental urination.
over time, increased bladder pressure can also lead to bladder and kidney damage.
There are a number of causes of neurogenic urinary muscle over-activity in children, such as transverse myocarditis, spinal cord injury, and spina bifida, which is most common and affects about 1,500-2,000 babies per year in the United States.
more than 90% of patients with spina bifida have urinary system symptoms.
the new adaptation approval, based on data from a randomized, double-blind Phase 3 study.
study was conducted in more than 100 children with neurogenic forced urinary muscle over-activity, assessed the safety and effectiveity of Botox, and conducted a long-term extended study. The results of the phase
3 study showed that Botox®200 units (no more than 6U/kg) of forced intra-urinary intramyal injections reduced the onset of urinary incontinence during the day, which was the main endpoint of the study, and reduced maximum bladder pressure and increased bladder capacity at week 6 (the primary point in time).
adverse reactions in the study were bacterial urine (20%), urinary tract infections (7%), leuria (7%) and blooduria (3%).
Botox is the first neurotoxin approved for children with under.com-control of anticholinergic uremia," said Mitchell F. Brin, Senior Vice President and Chief Scientific Officer, AbbVie BOTOX® and Neurotoxins, "Botox is the first neurotoxin approved for use in children with neurogenic uremia who have been under-controlled with anticholinergic drugs.
milestone marks Botox's 12th U.S. approval for therapeutic adaptation, adding another approved use to the pediatric portfolio.
based on our 30-year tradition of Botox research and development, we continue to pursue neurotoxin innovation to address unsolved medical needs throughout the therapeutic field.
"Many children with underlying neurological disorders may experience bladder and kidney damage over time, underscoring the importance of treatment," said Dr. Paul F. Austin, M.D., director of pediatric urology at Texas Children's Hospital and a professor of urology at Baylor College of Medicine.
in the care of neurogenic urethra overactive children, we strive to reduce bladder pressure and increase bladder capacity.
, in addition to surgery, treatment options are mainly limited to anticholinel drugs, but long-term use also need to be carefully considered.
effective management of neurogenic forced urinary muscle over-activity requires continuous care, and there is a high degree of unsolveed demand for alternative treatment options.
proven safety and ability of Botox will provide a new treatment option for pediatric patients receiving anticholinel drugs that do not adequately manage their condition.
"Botox, developed by Eljian (acquired by AbbVie), is a highly purified form of Botox A, a nerve-conducting blocker used to treat overactive muscles.
Botox was first approved in 1989 to treat face spasms and squints, and in 2000 was approved for neck dystase disorders before expanding further into the field of beauty, including wrinkle removal, thin faces, removal of eyebrows and fishtail lines.
in recent years, Botox has also been approved to treat a variety of adaptations such as upper limb spasms, chronic migraines, neurotic urinary incontinence, bladder over-activity, spasms and severe underarm sweating (underarm sweating).
Botox is the world's first approved type A botulinum toxin treatment.
, Botox has so far been approved by the FDA for 12 therapeutic adaptations.
over the past 30 years, more than 100 million bottles of Botox ® and Botox® Cosmetic have been sold worldwide, and more than 3,700 articles have been published in scientific and medical journals.
Botox® neurotoxin is one of the most widely studied drugs in the world.
() Origin: BOTOX? (onabotulinumtoxinA) Receives FDA approval for Pediatric Detrusor Overactivity Associated with a Neurologic Condition