WASHINGTON (AP) - The Food and Drug Administration said Tuesday
it approved Allergan's botulinum-based drug Botox to treat spasms
of the elbow, wrist and fingers.
Botox is most famous for it's ability to smooth frown lines on
aging foreheads, but the drug has long been used to treat neck
spasms, eye muscle disorders and excessive underarm sweating.
Under the latest FDA indication, Allergan will be able to market
Botox as a treatment for adults with spasticity in the flexor
muscles of the elbow, wrist, and fingers.
"Muscles affected by spasticity have increased stiffness and
tightness, which may lead to pain, difficulties with hygiene and
other activities of daily living, and may affect how a patient
looks," said Dr. Russell Katz, director of the FDA's division of
Allergan, which is based in Irvine, Calif., is studying Botox
for a variety of uses, including treating migraine headaches.
Botox works by blocking the connections between nerves and
muscle, temporarily paralyzing the spastic muscle. The drug is a
purified form of botulinum, one of the most toxic substances in the
FDA stressed in a statement that Botox is not approved to treat
spasms in larger muscles of the arms or legs. Last year the agency
added warnings to Botox about its potential to migrate from limbs
to other parts of the body, causing breathing problems.
Companies are prohibited from discussing unapproved drug uses
with doctors and patients.
But last year Allergan filed a lawsuit against the FDA
challenging that restriction. The company argues it has a First
Amendment right to educate doctors about how to safely use Botox to
treat limb spasms - even though that use is currently unapproved.
FDA's rules are designed to stop companies from promoting drugs
for uses that haven't been federally confirmed as safe and
effective. Companies caught promoting drugs for so-called off-label
uses can be subject to steep financial penalties.
Last year Pfizer Inc. paid $2.3 billion to settle allegations
that it marketed drugs for off-label use.
Preliminary hearings for Allergan's case are scheduled for next
month in U.S. District Court for the District of Columbia.
Allergan's shares jumped $2.14, or 3.5 percent, in after-hours
trading Tuesday following the FDA's announcement. They ended the
regular session down 19 cents at $61.35.
(Copyright 2010 by The Associated Press. All Rights Reserved.)