FDA Approves BOTOX (OnabotulinumtoxinA) For Lower Limb Spasticity

BOTOX® was first approved for the treatment of upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist and fingers, in adults in March 2010. Additional FDA approval was received in April 2015 to expand the BOTOX® label for the treatment of adults with ULS to include the addition of two thumb muscles. It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the best Botox in Las Vegas elbow, wrist, fingers, and thumb, or to treat increased stiffness in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.

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Botulin injections in the facial muscles, which relax expression lines and make one’s skin appear younger as a result of a mild paralysis, have another, not easily predictable effect: they undermine the ability to understand the facial expressions of other people. This consequence, as SISSA scientists explain in a new research study, depends on a temporary block of proprioceptive feedback, a process that helps us understand other people’s emotions by reproducing them on our own bodies.

BOTOX® Cosmetic is a purified protein produced by the Clostridium botulinum bacterium. The BOTOX® treatment procedure is a cosmetic elective out-patient, non-surgical, physician-administered injection of purified protein that can temporarily reduce moderate to severe frown lines between the brows. During treatment, very low doses of BOTOX® Cosmetic are administered via a few tiny injections directly into the muscles that cause those stubborn lines. The treatment is usually done in about 10 minutes, and usually minimal recovery time is needed.

Before receiving a botulinum toxin injection, tell your doctor if you have ALS ( Lou Gehrig’s disease), myasthenia gravis, Lambert-Eaton syndrome, a breathing disorder, trouble swallowing, facial muscle weakness, a change in the appearance of your face, seizures, bleeding problems, heart disease , if you have had or will have surgery, or if you have ever received other botulinum toxin injections such as Dysport or Myobloc.

The median duration of response in study NDO-1 and NDO-2, based on patient qualification for re-treatment was 295-337 days (42-48 weeks) for the 200 Units dose group compared to 96-127 days (13-18 weeks) for placebo. Re-treatment was based on loss of effect on incontinence episode frequency (50% of effect in Study NDO-1; 70% of effect in Study NDO-2).