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| |  AAN MEETING: Botox Promising As Migraine Treatment TORONTO, ON -- April 21, 1999 -- Allergan, Inc.’s Botox(R) (Botulinum Toxin Type A) Purified Neurotoxin Complex, an injectable biologic product, shows promise as a new treatment for migraine headaches, according to a new study presented today at the annual meeting of the American Academy of Neurology in Toronto. Treatment with Botox resulted in decreases in migraine frequency and severity over a three-month period according to researchers. An estimated 25 million Americans (3:1 as many women as men) suffer from migraine headaches, which are characterised by moderate to severe pain that is often localised to one side of the head and aggravated by movement or physical activity. An attack can last anywhere from four to 72 hours and may also be associated with nausea, vomiting and light and sound sensitivity. The current preventive treatments are often ineffective for many patients. "While strides have been made in the last few years in the ability to manage migraine symptoms, millions of people still find that migraines exert powerfully negative and debilitating effects on their lives," said Stephen Silberstein, M.D., director of the Jefferson Headache Center's department of neurology at Thomas Jefferson University Hospital and an investigator in the study. "The development of more effective preventive therapies would fill a huge gap in the treatment options available for these patients." Researchers found in a three month study that treatment with 25U Botox resulted in greater reductions than vehicle in the frequency of moderate-to-severe migraines during months two and three. "The clinical trial data offers promising results for the millions of people suffering from migraine headaches. The recent findings show the potential for reduction in frequency and severity of migraines. These findings may suggest the ability of Botox to prevent migraines at doses that are well-tolerated with minimal adverse events," said Ninan Mathew, M.D., of the Houston Headache Clinic and an investigator in the study. "Further studies will seek to identify ideal dose and sites of injection, as well as those patients most likely to benefit from treatment with Botox." The study reported today is part of an ongoing clinical program designed to evaluate Botox for the prevention and treatment of migraine. In addition, Botox is being studied as a treatment for a number of other disorders including cerebral palsy, cervical dystonia (involuntary muscle spasms in the neck and shoulders), post-stroke spasticity, back pain and tension headache. Botox was approved by the United States Food and Drug Administration in 1989 for the treatment of strabismus and blepharospasm associated with dystonia (disorder of the eye muscles that control blinking), including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above. Botox is the only botulinum toxin medical product currently approved for marketing in the U.S. Botox is a highly purified form of botulinum toxin Type A, which is produced by the bacteria, clostridium botulinum. It is administered as an injectable product containing minute quantities of the isolated toxin that contains no intact clostridium botulinum bacteria. When injected directly into overactive muscles, Botox inhibits the release of acetylcholine, a neurotransmitter released from nerve endings that causes muscles to contract. The result is inhibition, or relaxation, of the muscle overactivity.
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