FDA Approves Botox for Arm Spasticity in Adults; Allergan's Case Against Govt Still Active

Yesterday the FDA approved Botox (onabotulinumtoxin A; Allergan) to treat distal arm spasticity in adults.* The approval was based on results from at least 3 trials in a total of 305 people with arm spasticity after stroke. Two of the 3 studies have been published in peer-reviewed journals (see here and here).

While the FDA's new approval partially mitigates the legal issue that Allergan has had with the agency's mandate to disseminate off-label safety information about Botox (for necessary background, go here, here, here, and here), it does not resolve the problem with respect to the use of Botox for limb spasticity in children—a still unapproved indication.

The case of Allergan v the United States of America et al was scheduled for a motion hearing in the US District Court for the District of Columbia on March 2nd. However, the docket has evidently been altered. According to the current court calendar, a status conference is scheduled for March 25th in the chambers of Judge John D. Bates, and a motion hearing is scheduled for April 26th.

* Specifically the flexor muscles of the elbow (eg, biceps), wrist (eg, flexor carpi radialis), and fingers (eg, flexor digitorum profundus).

Image of deep muscles of the ventral forearm from Gray's Anatomy (1918).