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BOTOX ® The Real Facts David H. Hammett, M.D. Neurology March 26, 2012.

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Presentation on theme: "BOTOX ® The Real Facts David H. Hammett, M.D. Neurology March 26, 2012."— Presentation transcript:

1 BOTOX ® The Real Facts David H. Hammett, M.D. Neurology March 26, 2012

2 4540 Trenholm Road Columbia, SC (803)

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5 Introduction to BOTOX ® How does BOTOX ® Work? BOTOX ® in the Treatment of Blepharospasm BOTOX ® in the Treatment of Cervical Dystonia BOTOX ® for Severe Primary Axillary Hyperhidrosis BOTOX ® in the Treatment of Spasticity BOTOX ® in the Treatment of Chronic Migraine Important Information About BOTOX ® Presentation Overview

6 History In the 1820s, the biological basis for food poisoning was not understood. Studies began on a batch of improperly prepared sausages responsible for the death of several dozen people in Germany. First suggestion that there was something in the spoiled sausages that brought on the disease. These experiments led to a better understanding of the neurological symptoms of food-borne botulism (ptosis, dysphagia, muscle weakness, and, if left untreated, paralysis and respiratory failure). These experiments led to a better understanding of the neurological symptoms of food-borne botulism (ptosis, dysphagia, muscle weakness, and, if left untreated, paralysis and respiratory failure).

7 History More than 70 years later, Dr. Emile Pierre van Ermengem of Belgium was asked to investigate an outbreak of botulism following a funeral dinner where three people died and 23 were paralyzed. Van Ermengem was able to make a connection between botulism and a spore-forming bacterium he named Bacillus botulinus (now known as Clostridium botulinum). Many scientific studies followed, and seven strains of botulinum toxin were eventually identified (A-G).

8 History In 1978, an Opthalmologist (Dr.Scott) received approval to inject minute amounts of botulinum toxin into human volunteers. In the early 1980s, he published a number of studies including a 1981 paper in the Transactions of the American Ophthalmological Society that asserted botulinum toxin appears to be a safe and useful therapy for strabismus. Additional research showed the drugs benefits went beyond ophthalmology, providing patients with temporary relief from facial spasms, neck and shoulder spasms, even vocal cord spasms.

9 History In 1988, drugmaker Allergan acquired the rights to distribute Scotts batch of botulinum toxin type A (or Oculinum, as it was then known) and a year later, the FDA approved botulinum toxin type A for the treatment of both strabismus and blepharospasm. Shortly thereafter, Allergan acquired Scotts company and changed the drugs name to the compact, catchy Botox.

10 1950s Scientists discover that botulinum toxin can reduce muscle spasms. 1960s/1970s Studies explore botulinum toxin as a treatment for strabismus (crossed eyes) Allergan researches other medical uses of botulinum toxin. BOTOX 1989 Allergan introduces BOTOX®, the first botulinum toxin approved by the FDA to treat blepharospasm (eyelid spasms) and strabismus FDA approves BOTOX® for cervical dystonia Timeline – Development and FDA

11 BOTOX® Cosmetic 2002FDA approves BOTOX® Cosmetic, (sameformulation as BOTOX®) for moderate to severe frown lines between the brow FDA approves BOTOX® for severe underarm sweating year anniversary of BOTOX® FDA approves BOTOX® for upper limb spasticity BOTOX® is approved by the FDA specifically for the prevention of headaches in adults with Chronic Migraine (15 or more days each month with headache lasting 4 or more hours each day) 2011FDA approval for neurogenic urinary incontinence Timeline – Development and FDA

12 Glabellar Frown Lines Glabellar frown lines are the most common reason for cosmetic injection of botulinum toxin.

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46 BOTOX ® (onabotulinumtoxinA) for Chronic Migraine Patients: A Prophylactic Treatment Paradigm Please see Indication, Important Limitations, and Important Safety Information, including Boxed Warning, throughout this deck.

47 Indication BOTOX ® (onabotulinumtoxinA) for injection is indicated for the prophylaxis of headaches in adult patients with chronic migraine (15 days per month with headache lasting 4 hours a day or longer). Important limitations Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies. 47

48 IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING Distant Spread of Toxin Effect Postmarketing reports indicate that the effects of BOTOX ® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses. 48 Please see additional Important Safety Information throughout this deck.

49 Diagnostic Criteria for Chronic Migraine Chronic Migraine is a defined condition 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 characteristics 1 ? 49 Patients should experience at least 2 of these pain characteristics: Unilateral Migrainous, pulsating quality Moderate to severe intensity Aggravated by routine physical activity And at least 1 of: Nausea and/or vomiting Photophobia and phonophobia 1.Headache Classification Committee; Olesen J et al. Cephalalgia. 2004;24: Headache Classification Committee; Olesen J et al. Cephalalgia. 2006;26: Lipton RB. Headache. 2011;51(S2):77·83. Please see Important Safety Information, including Boxed Warning, on slides Please see Important Safety Information, including Boxed Warning, throughout this deck.

50 Case Study: Emily Patient History: 43-year-old woman is seen for a main complaint of headache She has had headaches since her teens She reports 8 migraine attacks per month, each lasting 2–3 days She has migraine features (nausea, photophobia, and phonophobia) on all headache days She has tried multiple preventive medications 50 Please see Important Safety Information, including Boxed Warning, on slides Please see Important Safety Information, including Boxed Warning, throughout this deck. Case Studies do not involve actual patients

51 Study Design of Two Phase 3 Studies of Chronic Migraine Patients 1,2 Large clinical program of Chronic Migraine sufferers (1384 patients) Double-Blind Phase Open-Label Phase Primary Time Point BOTOX ® vs Placebo All Patients on BOTOX ® Phone Interview Treatment BaselineRandomization Weeks Day 0 24 BOTOX ® vs Placebo (saline) BOTOX ® 1.Aurora SK et al. Cephalalgia. 2010;30: Diener HC et al. Cephalalgia. 2010;30: Headache symptoms and medications were recorded in a daily telephone diary Please see Important Safety Information, including Boxed Warning, throughout this deck. 51

52 Efficacy of BOTOX ® at Week 24 for Study 1 and Study 2 52 BOTOX ® (onabotulinumtoxinA) Prescribing Information. Allergan, Inc., *Significantly different from placebo (p0.05) Please see Important Safety Information, including Boxed Warning, throughout this deck.

53 Adverse Reactions Reported by 2% of Patients Treated With BOTOX (More Frequent Than Placebo) in Two Chronic Migraine Double-Blind, Placebo-Controlled Clinical Trials 1 53 *Aurora et al 2011 reported n=38 (5.5%); 2.2% of the incidences of muscular weakness were facial paresis BOTOX ® (onabotulinumtoxinA) Prescribing Information. Allergan, Inc., Aurora SK et al. Headache. 2011;51: Severe worsening of migraine requiring hospitalization occurred in approximately 1% of patients treated with BOTOX ® in Study 1 and Study 2, usually within the first week after treatment, compared to 0.3% of placebo-treated patients. Please see Important Safety Information, including Boxed Warning, throughout this deck.

54 Discontinuation Rates 54 *The most frequent adverse events leading to discontinuation in the BOTOX ® group were neck pain, headache, worsening migraine, muscular weakness, and eyelid ptosis. BOTOX ® (onabotulinumtoxinA) Prescribing Information. Allergan, Inc., Please see Adverse Reactions table on slides 12 and 24. Please see Important Safety Information, including Boxed Warning, throughout this deck.

55 Injection Paradigm The phase 3 BOTOX ® pivotal studies for Chronic Migraine patients has established a treatment paradigm 1 The patient population, recommended dose, and injection paradigm were established based on 10 years of studies assessing various patient types, muscle groups, and doses Units of BOTOX ® are administered as 31 fixed-site, fixed- dose injections across 7 specific head/neck muscle areas 1 For each injection site, the injection volume will be 0.1 mL (5 Units) 1 Each muscle has a fixed 1 : Total dose Number of injection sites Location of injection sites 1. Blumenfeld AM et al. Headache. 2010;50: Mathew NT et al. Headache. 2005;45: Silberstein SD et al. Mayo Clin Proc. 2005;80: Silberstein SD et al. Headache. 2000;40: Binder WJ et al. Otolaryngol Head Neck Surg. 2000;6: Freitag FG et al. Headache. 2008;48: Please see Important Safety Information, including Boxed Warning, throughout this deck.

56 Case Study: Emilys Response to Treatment 2 Weeks Post-Injection Follow-up visit 2 weeks post- injection: Emily is still experiencing headaches due to Chronic Migraine She also now has neck pain She feels dissatisfied and hopeless and is not sure if she wants to continue with BOTOX ® treatments 56 In PREEMPT 1 and 2, the first evaluation was 4 weeks post-injection. Please see Important Safety Information, including Boxed Warning, throughout this deck. Case Studies do not involve actual patients

57 Case Study: Monitoring Emilys Response to Treatment Second Injection Cycle: Emily has returned for her second BOTOX ® treatment Follow-up with the patient You continue to monitor and document Emilys response to treatment 57 Please see Important Safety Information, including Boxed Warning, throughout this deck. Case Studies do not involve actual patients

58 Injection Sites: Corrugator and Procerus Corrugator: 10 Units divided in 2 sites Procerus: 5 Units in 1 site 5 Units BOTOX ® at each site (0.1 mL injected) BOTOX ® (onabotulinumtoxinA) Prescribing Information. Allergan, Inc., Please see Important Safety Information, including Boxed Warning, on slides Please see Important Safety Information, including Boxed Warning, throughout this deck.

59 Injection Sites: Frontalis Region Frontalis: 20 Units divided in 4 sites BOTOX ® (onabotulinumtoxinA) Prescribing Information. Allergan, Inc., Units BOTOX ® at each site (0.1 mL injected) 59 Please see Important Safety Information, including Boxed Warning, on slides Please see Important Safety Information, including Boxed Warning, throughout this deck.

60 Injection Sites: Temporalis Having the patient clench teeth will produce a palpable anterior bulge to the temporalis muscle, directing the anterior injection site Temporalis: 40 Units divided in 8 sites BOTOX ® (onabotulinumtoxinA) Prescribing Information. Allergan, Inc., Units BOTOX ® at each site (0.1 mL injected) 60 Please see Important Safety Information, including Boxed Warning, throughout this deck.

61 Injection Sites: Occipitalis Occipitalis: 30 Units divided in 6 sites Nuchal ridge BOTOX ® (onabotulinumtoxinA) Prescribing Information. Allergan, Inc., Units BOTOX ® at each site (0.1 mL injected) 61 Please see Important Safety Information, including Boxed Warning, on slides Please see Important Safety Information, including Boxed Warning, throughout this deck.

62 Cervical paraspinal muscle group: 20 Units divided in 4 sites Trapezius: 30 Units divided in 6 sites Injection Sites: Cervical Paraspinal Muscle Group and Trapezius BOTOX ® (onabotulinumtoxinA) Prescribing Information. Allergan, Inc., Units BOTOX ® at each site (0.1 mL injected) 62 Please see Important Safety Information, including Boxed Warning, on slides Please see Important Safety Information, including Boxed Warning, throughout this deck.

63 BOTOX ® : The Real Facts Summary Questions


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