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FDA Accepts Botox (OnabotulinumtoxinA) Resubmission for Treatment of Lower-Limb Spasticity in Adults

Approval decision expected in early 2016

The FDA has accepted the resubmission of a supplemental biologics license application (sBLA) for Botox (onabotulinumtoxinA, Allergan) for the treatment of adults with lower-limb (involving ankle and toe muscles) spasticity in adults. A 6-month review period has been assigned for the sBLA. The Prescription Drug User Fee Act (PDUFA) date is expected to be in the first quarter of 2016.

The resubmission provides additional data from a double-blind, placebo-controlled study involving 468 patients with lower-limb spasticity.

In April 2015, the FDA approved an expansion of the Botox label for the treatment of adults with upper-limb spasticity. The expanded label now includes the addition of two thumb muscles: flexor pollicis longus, a muscle in the forearm that flexes the thumb; and adductor pollicis, a muscle in the hand that functions to adduct the thumb; increasing the maximum dose from 360 to 400 units for the treatment of upper-limb spasticity. The FDA also approved an increase to the maximum Botox cumulative dose within 3 months from 360 to 400 units in adults treated for one or more indications.

Botox is a prescription medication that is injected into muscles and is used to treat increased muscle stiffness in elbow, wrist, finger, and thumb muscles in people 18 years of age and older with upper-limb spasticity.

It is not known whether Botox is safe or effective for the treatment of increased stiffness in upper-limb muscles other than those in the elbow, wrist, fingers, and thumb, or for the treatment of increased stiffness in lower-limb muscles. Botox has not been shown to help people perform task-specific functions with their upper limbs or to increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with Botox is not meant to replace existing physical therapy or other rehabilitation that doctors may have prescribed.

Botox may cause serious side effects that can be life-threatening. Problems swallowing, speaking, or breathing due to weakening of associated muscles can be severe and can result in loss of life. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness, double vision, blurred vision, drooping eyelids, dysphonia, dysarthria, loss of bladder control, trouble breathing, and trouble swallowing.

Source: Allergan; August 20, 2015.

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