FDA approves expanded Botox label for treatment of upper-limb spasticity in adults

FDA approves expanded Botox label for treatment of upper-limb spasticity in adults Actavis recently announced the FDA has approved an expansion of the Botox label for the treatment adults with upper-limb spasticity.

The expanded label for Botox (onabotulinumtoxinA, Allergan) includes the addition of two thumb muscles, the flexor pollicis longus and adductor pollicis, and increases the maximum dose from 360 units to 400 units for the treatment of upper-limb spasticity, according to a press release from Actavis, which recently completed the acquisition of Allergan. An increase of the maximum cumulative dose of onabotulinumtoxinA within 3 months from 360 units to 400 units in adults treated for one or more indications also was approved by the FDA, according to the release.

The approval expands the therapy’s previous approval in 2010, in which onabotulinumtoxinA is injected into muscles and used to treat increased muscle stiffness in the elbow, wrist and finger muscles of patients ages 18 years and older with upper-limb spasticity.

The results of two randomized, multicenter, double-blind, placebo-controlled studies that measured efficacy and safety of Botox in patients with upper-limb spasticity served as the basis for the FDA’s approval of the expanded label, according to the release.

OnabolutlinumtoxinA is marketed by Allergan as Botox and Botox Cosmetic, which was approved for separate indications by the FDA in 2002.

References: www.actavis.com; www.allergan.com.