Botox Approved for Treatment of Lower Limb Spasticity

The FDA has approved onabotulinumtoxinA (Botox) as a treatment for adults’ lower limb spasticity by lessening muscle stiffness in ankle and toe muscles.

Allergan noted in a press release that Botox is the first and only FDA-approved neurotoxin treatment for both upper and lower limb spasticity.

Botox was initially approved for upper limb spasticity or stiffness in the elbow, wrist, and fingers in March 2010, and its use was expanded in April 2015 to include treatment of 2 thumb muscles.

"Spasticity is a debilitating condition that can have a significant impact on patients' lives, compromising their ability to perform a range of daily activities," said Mitchell Brin, senior vice president, Global Development, and scientific officer for Botox, in a press release. "This FDA approval marks our continued commitment to partnering with scientists and researchers around the world to explore the potential benefits of Botox in treating specific medical conditions.”

Botox has not been proven to help people perform tasks with their upper limbs, and it is not meant to replace existing physical therapy.

The FDA based its recent decision on information from a study involving 400 patients with lower limb spasticity following stroke.

Adverse effects of Botox may include dry mouth, discomfort at the injection site, and tiredness.

However, some more serious adverse effects related to allergic reactions have been reported. These symptoms include rash, itchy welts, wheezing, and dizziness.