The Food and Drug Administration said it has approved Botox, a drug made by Irvine-based Allergan Inc., for treating upper-limb muscle spasms.
Under the regulators’ action, Allergan will be able to market Botox, a purified form of botulinum toxin, to treat adults with spasms of the elbow, wrist and fingers.
Muscles affected by spasticity occur in about 1 million Americans, according to Allergan.
The condition generally affects people in the elbow, wrist and fingers following a stroke, spinal cord injury, multiple sclerosis or those with a history of cerebral palsy.
Allergan is looking at Botox for various uses, including treating migraine headaches. Its best known in its cosmetic form as a wrinkle remover.
The drug, which is expected to have sales of $1.33 billion to $1.37 billion in 2010, works by blocking the connections between nerves and muscle, or temporary paralyzing the muscle that is having spasms.
In a release, the drug maker said the spasm treatment approval is the sixth for Botox in the U.S.
But the FDA said in its own release that Botox isn’t approved to treat spasms in larger arm or leg muscles. Regulators added warnings to the drug about its potential to migrate from limbs to other parts of the body and cause breathing problems.
