Botox ™, 11/1993

BOTOX" is the commercial name given to a preparation made from Clostridium botulinum, a bacterium that causes a serious form of food poisoning. The food poisoning blocks the transmission of the nerve impulse from a nerve to a muscle, causing muscle weakness or paralysis.

The effect of BOTOX" is to relieve muscle spasm, generally within three days after its injection into a spastic muscle. The effects of each injection lasts approximately three months; sometimes it may be as long as six months before another injection of BOTOX" is needed. It is suggested that once severe muscle spasms have been relieved, physical therapy may be more effective in building muscle strength and coordination.

Studies of BOTOX"'s usefulness in treating muscle spasms in humans were begun in 1973. Since then, BOTOX" has been studied for treating a variety of conditions involving inappropriate muscle activity. When injected into specific places in selected muscles, BOTOX" has been found useful in treating muscle spasms affecting vision (strabismus and blepharospasm). It has also been found useful in treating long term spasticity in neck muscles as well as in treating spasticity in the throat muscles affecting speech. A number of persons with these disorders have been following for several years, and there have been few reports of side effects. Most difficulties appear to be relatively mild and of short duration. The use of BOTOX" for specific disorders of eye and facial muscles has been approved by the U.S. Government Food and Drug Administration.

Because of the above, it has been proposed that BOTOX" may be useful for relieving muscle spasticity in persons with cerebral palsy. Allergan which produces BOTOX", is conducting a clinical trial of its effectiveness in selected medical centers around the country. The clinical trial is in its final phases, and information about the effectiveness of BOTOX" in treating muscle spasticity associated with cerebral palsy should be available by mid-1994.

Further information about the trial and the names of participating centers can be obtained by writing to:

Ms. Elisabeth Sandovol

Allergan, Inc.

2525 Dupont Drive

Irvine, CA 92715