Botox Receives New Pediatric Indication
June 21, 2019 – The U.S. FDA has approved a new pediatric indication for Botox® (onabotulinumtoxinA), manufactured by Allergan, to treat patients between two and 17 years old who have upper limb spasticity. According to the manufacturer, the product is also undergoing FDA review for approval to treat pediatric patients who have lower limb spasticity, with a decision expected in the fourth quarter of 2019.
Spasticity occurs when muscles become short and stiff, and can cause involuntary muscle spasms. It is usually the result of damage to the nervous system. Children often suffer spasticity due to cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke. The condition can make it difficult to maintain balance and posture, as well as perform day-to-day activities such as getting dressed. It can also be painful, and the severity of the condition ranges from mild to severe. Upper limb spasticity affects the arms, including the hands, wrists, and elbows.
Previously approved to treat upper and lower limb spasticity in adults, Botox was approved for pediatric patients based on data from two studies that evaluated its safety and efficacy in over 200 pediatric patients with upper limb spasticity. These trials included a 12-week, double-blind study and a one-year open-label extension study.
Recommended dosing under the new indication is 3-6 units/kg of body weight per treatment, divided among the affected muscles. The total dose of Botox administered per treatment session should not exceed 6 units/kg or 200 units total, whichever is lower. The maximum cumulative dose should not exceed the lower of 8 units/kg or 300 units total in a three-month interval. Botox is not interchangeable with other botulinum toxin products. Like other botulinum toxin products, it carries a black box warning that its effects may spread beyond the targeted sites hours or weeks after injection. This may lead to potentially life-threatening difficulties swallowing or breathing. The risk may be greatest in children treated for spasticity.
First approved in 1989, Botox holds FDA approval for nine non-cosmetic indications.