So, what is a Migraine Headache? Migraine Definition At least 2 of the following: • Moderate to severe pain • One sided • Throbbing or pulsating in character • Worsening with movement or bending over & At least one of the following: • Nausea and/or vomiting • Sensitivity to lights, sounds or smells Other Common Migraine Symptoms • • • • • • • • Precipitated by certain foods, alcohol, stress, sleep patterns Peri-menstrual 60% of the time involves the neck region Strong family history (“sick headaches”) 3:1 female Worsened with bending over (it’s not your sinuses!) Next day “hang-over headache” Responds to caffeine FAMOUS MIGRAINEURS Botox Binds to the Nerve Terminal Botox is Internalized into the Nerve Ending Botox Cleaves SNAP-25 Now the nerve can’t release acetylcholine and tell the muscle to contract, so your wrinkles are gone!) ( After 3 months, new nerve sprouts develop (and your wrinkles return) Eventually the sprouts retract and the original nerve ending regains its normal function (That’s why Botox is re-injected every 3 months) Beverly Hills, CA October 15, 2010 William J. Binder M.D., F.A.C.S. Inc., Beverly Hills plastic surgeon and pioneer in the cosmetic (anti-wrinkle) and therapeutic use of the BOTOX® neurotoxin, made headlines in the early 1990’s by discovering that BOTOX was effective in relieving the pain and preventing the onset of migraine headaches. Friday the U.S. Federal Drug Administration (FDA) approved BOTOX injections as a preventative treatment for chronic migraine sufferers. Botox is only approved for “Chronic Migraine” • • So, what constitutes a “Chronic Migraine”? . Diagnostic Criteria for Chronic Migraine • Chronic Migraine is a defined condition1-3 • • • • 15 or more headache days per month Headaches lasting 4 hours per day or more At least 8 headache days classified as migraine days With or without medication overuse • What are migraine characteristics1? Patients should experience at least 2 of these pain characteristics: And at least 1 of: Unilateral Nausea and/or vomiting Migrainous, pulsating quality Photophobia and phonophobia Moderate to severe intensity Aggravated by routine physical activity 1. Headache Classification Committee; Olesen J et al. Cephalalgia. 2004;24:9-160. 2. Headache Classification Committee; Olesen J et al. Cephalalgia. 2006;26:742-746. 3. Lipton RB. Headache. 2011;51(S2):77·83. 14 PAR IV Movies Presents: • Reality vs. Insurance Companies So, how do we inject Botox for Chronic Migraine? Please see Important Safety Information, including Boxed Warning, throughout this deck. BOTOX® for Chronic Migraine Patients: Recommended Order of Injection* per Phase 3 Injection Paradigm1 Order* Muscle A Corrugator† B Procerus C Frontalis† 20 Units divided in 4 sites D Temporalis† 40 Units divided in 8 sites E Occipitalis† 30 Units divided in 6 sites F Cervical paraspinals† 20 Units divided in 4 sites G Trapezius† 30 Units divided in 6 sites Total number of Units Total Dosage (Number of Sites**) 10 Units divided in 2 sites 5 Units in 1 site 155 Units divided in 31 sites * Recommended order of injection based on phase 3 injection paradigm; table in prescribing information differs. ** Each IM injection site = 0.1 mL = 5 Units BOTOX®. † Dose distributed bilaterally. Dosing and results in these studies are specific to the formulation of BOTOX® manufactured by Allergan, Inc. (Irvine, CA). The Allergan, Inc., formulation is not interchangeable with other botulinum toxin products and cannot be converted using a dose ratio. Patient is in supine position2 Patient is in sitting position2 17 1. BOTOX® (onabotulinumtoxinA) Prescribing Information. Allergan, Inc., 2011. 2. Blumenfeld AM et al. Headache. 2010;50:1406-1418. Facial Muscles Questions, comments, alternative speeches