Botox ™ - Update 12/1995

In November 1993, a Foundation Research Fact Sheet discussed the status of BOTOX" in the treatment of the muscle spasticity associated with cerebral palsy.

In summary of the November 1993 Fact Sheet: BOTOX" is used to relieve muscle spasm by blocking the transmission of the nerve impulse to a muscle, causing the muscle to be weakened or paralyzed. It is administered by fine needle injection into one or more spastic muscles, usually taking effect within three days and often lasting three to six months. The relief of spasticity by BOTOX" injections is usually followed by an organized program of physical therapy. BOTOX" has been approved by the U.S. Food and Drug Administration for use in specific disorders of the eye and of facial and neck muscles. It is available to physicians through pharmacies. BOTOX" has been undergoing evaluation for relieving the muscle spasticity in the extremities that is associated with cerebral palsy. Readers are referred to the November 1993 Foundation Research Fact Sheet for additional background information.

A number of clinical trials of BOTOX" for use in relieving limb spasticity in persons with cerebral palsy have now been completed. The data have been submitted to the U.S. Food and Drug Administration (FDA) for approval of its use for this purpose. As of now, the FDA review has not been completed.

At the 1995 Annual Meeting of the American Academy of Cerebral Palsy and Developmental Medicine, a number of research papers were presented on the clinical evaluation of BOTOX". In general, the results reported were favorable. There were reports of meaningful improvements in limb positioning and of some improvement in gait of selected patients; other patients had minimal results. The persons most likely to benefit were young people, with no tendon contractures and who do not have significant spasticity of muscles in the thigh.

Comment:

The final story on the use of BOTOX" is not yet available. Hopefully, the information submitted to the FDA and the evaluation of those data will be made available in the near future. In the interim, physicians are continuing to explore the use of BOTOX" in muscle spasticity due to cerebral palsy. Some physicians suggest that a trial of BOTOX" is a reasonable way to evaluate what effects selective dorsal rhizotomy may have on spasticity and on gait. However, we must remember that the basic problem is lack of muscle coordination, not muscle disease. An improvement in limb positioning may be the reason for the benefit in gait. Additional information about the use and availability of BOTOX" can be obtained by writing to:

BOTOX"

Allergan, Inc.

2525 Dupont Drive

Irvine, CA 92715