Wrinkle-Reducing Botox® Shown to Treat Migraine Headaches
Dr. William J. Binder, discovered the use of BOTOX® for the treatment of migraine headaches.
The initial findings were presented by Dr. Binder at the 15th Annual Scientific Meeting of the American Academy of Cosmetic Surgery (AACS) in January 1999, and at the American Academy of Facial Plastic and Reconstructive Surgeons in May 1999, at the Annual Meeting of the American Association for the Study of Headache (AASH) in June 1999. The final data of the original study was presented at the Annual Meeting of the American Academy of Otolaryngology and Head and Neck Surgery in New Orleans on September 28, 1999.
HOW IT WAS DISCOVERED:
While conducting these studies in 1992, Dr. Binder noticed a correlation between the use of BOTOX® and the alleviation of pain in his patients who also had migraine headache symptoms. Many of these patients reported either total elimination or decreased migraine pain following the BOTOX® treatment. Dr. Binder then continued to study these effects for two more years and devised an initial protocol which was used in a combined multi-center, open label study to assess the efficacy of BOTOX® in the prophylactic management of migraine headaches and related symptoms. This protocol proved that BOTOX® did work to reduce the pain of migraine.
WHAT IS MIGRAINE HEADACHE?
Migraines are an episodic disorder with neurologic, gastrointestinal and autonomic symptoms. An estimated 23 million Americans (17% of women and 6% of men) suffer from migraines, which are characterized by moderate to severe head pain aggravated by movement or physical activity. An attack can last anywhere from 4 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 and long-acting, well-tolerated, prophylactic therapy is needed. 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. It is estimated that the effects of migraine costs the U.S. economy approximately $17 billion dollars a year due to loss of work productivity. The development of more effective preventive therapies is needed, since there is still a huge gap in the current treatment options available for these patients.
In the original published study, 100 patients were treated with BOTOX®. Combining both prophylactic and acute cases, there were a combined total of 110 treatments. The results of treatment showed that approximately 50% had complete improvement; 32% had partial improvement; and about 17% had no response. In those patients treated prophylactically, the average duration of benefit remained for approximately three to three-and-one-half months. Adverse effects were minimal, limited to transient local pain and bruising at the injection site. Based on the results in this study, the authors concluded that BOTOX® was a safe, effective and therapeutic treatment for the relief of migraine headache disorders. Subsequent to Dr. Binder’s studies, there have been well over 100 articles, studies and data to confirm the original findings. These clinical trials offer promising results for the millions of people suffering from migraine headaches. It suggests the ability of BOTOX® to prevent migraines at doses that are well-tolerated, with no systemic side effects and minimal local adverse effects. Formal FDA studies have been ongoing and Phase III clinical trials are currently being completed. These studies include the largest and most prominent headache clinics in the United States and Europe.
Based on Dr. Binder’s discovery: The following are answers to some commonly asked questions about BOTOX® and migraine.
How is BOTOX® used for Migraine and where is it injected?
A series of small injections of BOTOX® are given in specific areas across the frontal, temporal and glabellar regions of the forehead. In some instances, it is also injected into the back of the neck. The treatment takes about fifteen minutes and it can provide pain relief for up to three or more months.
How does B0TOX help to relieve migraines?
The exact way that BOTOX® works to relieve migraines is not yet known. Botulinum toxins are known to have a blocking ability not only at the neuro-muscular junction but at the cellular level as well. It is suggested that BOTOX® actually inhibits pain pathways through multiple actions at the neurotransmitter level and pain fiber level.
How does BOTOX® compare to other migraine treatments?
BOTOX® cannot be compared to other treatments. In those patients where Botox was effective, it eliminated pain and related symptoms of migraine (nausea, vomiting, photophobia, etc) for approximated 3 months. There is no other therapy that has this prophylactic ability. By way of comparison, the widely prescribed triptan class of agents (such as Imitrex®) are commonly used as treatment only during or before an acute onset of migraine and have a duration of action for only hours.
Is FDA approval for the use of BOTOX® in Migraine being pursued?
Yes. Allergan, the manufacturer of BOTOX®, is currently in Phase III clinical development for the use of BOTOX® for migraines. Completed Phase II trials concluded that BOTOX® reduced the frequency of migraines. Ongoing studies continue to evaluate the use of BOTOX® for migraines identifying the most appropriate dose and injection sites, determining its duration of action, and identifying those subgroups of patient most likely to receive treatment benefit.
Does BOTOX® work on other types of headache?
In the current study by Dr. Binder and associates, BOTOX® was shown to also benefit chronic daily headaches and tension-type headaches as well. The results, however, were not as consistent as with group of patients diagnosed with true migraine headaches.
Is BOTOX® treatment for Migraines currently reimbursed?
Reimbursement for BOTOX® migraine treatment is highly dependent upon the discretion of individual insurance carriers, based on review of the available scientific literature and physician recommendation’s of clinical benefit on a case-by-case basis.
BOTOX® THE DRUG:
What is BOTOX®?
BOTOX® is a purified form of a neurotoxin, botulinum toxin Type A and is made from the bacteria Clostridium Botulinum. It is administered in minute quantities in a highly purified form of the isolated toxin that contains no intact bacteria.
How does BOTOX® work to reduce muscle activity?
When injected directly into overactive muscles, BOTOX® inhibits the release of acetylcholine, a neurotransmitter released from nerve endings that causes muscles to contract. This blocks the nerves impulses and results in inhibition, or relaxation, of the muscle. After injection, it takes 2-3 days for BOTOX® to begin taking effect. The effect lasts for 3 months or longer and is reversible.
Is BOTOX® approved by the FDA?
BOTOX® is approved by the U.S. Food and Drug Administration (FDA) for the treatment of strabismus and blepharospasm, (disorder of the eye muscles that control blinking), benign essential blepharospasm or VII nerve disorders, treatment of glabella furrows (frown lines), hyperhydrosis, cervical dystonia and other spastic disorders. It is not yet approved for the treatment of migraine headaches. BOTOX® is the only botulinum toxin medical product currently approved for marketing in the U.S.
Is BOTOX® safe?
The safety profile of BOTOX® is considered to be excellent. BOTOX® has been used by patients with various conditions for over 20 years in over 60 countries. The most common side effects are localized pain, tenderness or bruising at the site of injection. These side effects are normally local and transient in nature.
Can patients get botulism from using BOTOX®?
The BOTOX® formulation does not contain the intact bacteria, Clostridium botulinum. Therefore, use of BOTOX® cannot cause botulism. Toxicity from the use of BOTOX® is rare due to the minute quantities of botulinum toxin injected for clinical uses. It is estimated that over 3000 units would be required to actually cause illness.