IRVINE, Calif.--(BUSINESS WIRE)-- Allergan, Inc. (NYSE: AGN) today announced the United States Food and Drug Administration (FDA) has approved BOTOX® (onabotulinumtoxinA) for the prophylactic (preventive) treatment of headaches in adults with Chronic Migraine,1 a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer.1,2 BOTOX® is the first clinically studied prophylactic treatment to be approved by the FDA specifically for this debilitated patient population.3 When injected at labeled doses and in the recommended locations in the head and neck, BOTOX® is expected to produce results lasting up to three months depending on the individual patient.1,3
It is estimated that Chronic Migraine impacts approximately 3.2 million* Americans,4 and can leave sufferers in pain for at least half of every month. The World Health Organization (WHO) ranks migraine as the 19th most disabling disease and notes that a day lived with severe migraine can be more disabling than blindness, paraplegia, angina (after walking 50 meters) or rheumatoid arthritis.5,6
Although Chronic Migraine occurs in both men and women, women are three times more likely than men to suffer from migraines.2 Sufferers often experience depression and anxiety as part of the condition.5 Chronic Migraine also can be influenced by life stress, sleep habits, diet and overuse of acute medications that relieve pain associated with symptoms of headache.7
“Chronic Migraine is a debilitating but under-recognized neurological condition. Often times, Chronic Migraine patients mistakenly self-diagnose their symptoms as headaches or infrequent migraine and treat them with drugs that provide rapid, but temporary, relief rather than seeking an evaluation, diagnosis and treatment from a qualified headache specialist,” said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer. “With BOTOX® approved by the FDA for Chronic Migraine patients, there is now a new preventive treatment option to reduce the days and hours spent in pain as a result of this condition.”
It is estimated that approximately 80 percent of those who meet the definition of Chronic Migraine have not received an accurate diagnosis8 and, as a result, may be unaware of their treatment options. This may be due to mischaracterization of Chronic Migraine as a less severe headache disorder.8
“Patients who think they may have Chronic Migraine should seek advice from a medical specialist, such as a neurologist, headache or pain physician, who is qualified to evaluate, diagnose and properly manage this condition and see if BOTOX® treatment is right for them,” said Sheena K. Aurora, M.D., Director, Swedish Headache Center, Seattle, Washington. “Effective management of the Chronic Migraine patient requires an analysis of headache type, triggers, co-morbidities and current medications to develop an appropriate treatment plan. The FDA approval of BOTOX® offers a new, clinically evaluated and proven option to help Chronic Migraine sufferers reduce the number of hours and days they suffer from headache for up to three months per treatment.”
When treating Chronic Migraine, qualified medical specialists administer 31 injections of BOTOX® neurotoxin into seven specific head and neck sites for a total of 155U per treatment session.1,3
PREEMPT: The Largest Clinical Trial Program in Chronic Migraine
BOTOX® (onabotulinumtoxinA) was approved by the FDA based on data collected in Allergan’s PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy) program. The program was designed to evaluate the safety and efficacy of BOTOX® as a preventive treatment of headaches in adults with Chronic Migraine.3,9 PREEMPT is the largest clinical program in Chronic Migraine, consisting of two double-blind, placebo-controlled clinical trials involving 1,384 adults from 122 study sites in North America and Europe.3,9 The PREEMPT studies were published in the March 2010 issue of Cephalalgia (available at: http://cep.sagepub.com/content/30/7.toc)
In both PREEMPT studies, patients treated with BOTOX® experienced a significantly greater decrease in the frequency of headache days from baseline compared to patients treated with placebo at the week 24 primary endpoint (7.8 and 9.2 fewer days for the BOTOX® group, versus 6.4 and 6.9 days for the placebo group, respectively).3,9 Also at week 24, patients treated with BOTOX® experienced a total cumulative reduction in headache hours by 107 and 134 hours, respectively, compared to 70 and 95 hours, respectively, in patients treated with placebo.3,9 Patients treated with BOTOX® also had a significantly greater mean decrease from baseline in the frequency of headache days at most timepoints from week four to week 24 in the first study, and all timepoints from week four to week 24 in the second study, compared to patients treated with placebo.3,9
In both PREEMPT studies, adverse reactions reported by greater than two percent of patients treated with BOTOX® and more frequent than in patients treated with placebo included headache, migraine and facial paresis, eyelid ptosis (eyelid drooping), bronchitis, musculoskeletal and connective tissue disorders, including neck pain, musculoskeletal stiffness, muscular weakness, myalgia (muscle pain), musculoskeletal pain and muscle spasms, injection site pain and hypertension.3,9 Severe worsening of migraine requiring hospitalization occurred in approximately one percent of patients treated with BOTOX® in both studies, usually within the first week after treatment, compared to 0.3 percent of patients treated with placebo.3,9 In general, BOTOX® treatment was well tolerated by the large majority of patients and the discontinuation rate due to adverse events was low in both treatment arms (four percent in the BOTOX® treated group and one percent in the placebo group).3,9 Full safety information is provided on page four of this press release.
About BOTOX® (onabotulinumtoxinA)
BOTOX® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. BOTOX® has a unique, protected molecular structure that stabilizes the core toxin in BOTOX® from degradation. When injected at FDA-approved and labeled doses into a specific muscle or gland, BOTOX® neurotoxin is expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three months depending on the individual patient. In the PREEMPT studies, none of the study participants suffering from Chronic Migraine demonstrated neutralizing antibodies to BOTOX® at study completion.
BOTOX® was first approved by the FDA 21 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval, BOTOX® has been recognized by regulatory authorities worldwide as an effective treatment for 21 different indications in approximately 80 countries, benefiting millions of patients worldwide. In the United States, BOTOX® neurotoxin is also approved to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults, symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough, as well as for the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in adult patients with upper limb spasticity.
In addition to its therapeutic uses, the same formulation of BOTOX® with dosing specific to moderate to severe glabellar lines was approved by the FDA in 2002 under the trade name BOTOX® Cosmetic (onabotulinumtoxinA). BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age. BOTOX® now approved by the FDA for the prophylactic treatment of headaches in adults with Chronic Migraine, marks the sixth therapeutic indication for the product in the United States since 1989.
In addition to 21 years of clinical experience, the safety and efficacy of BOTOX® have been well-established in approximately 50 randomized, placebo-controlled clinical trials and in approximately 11,000 patients treated with BOTOX® and BOTOX® Cosmetic in Allergan’s clinical trials.10 Worldwide, approximately 26 million vials of BOTOX® and BOTOX® Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1989-2009).11 With approximately 2,300 articles on BOTOX® and BOTOX® Cosmetic in scientific and medical journals,12 BOTOX® neurotoxin is one of the most widely researched medicines in the world.
BOTOX® (onabotulinumtoxinA) and BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® is a prescription medicine that is injected into muscles and used:
- to treat headaches in adults with Chronic Migraine (15 or more days with headaches lasting four hours a day or longer) in people 18 years or older.
- to treat increased muscle stiffness in elbow, wrist, and finger muscles with upper limb spasticity in people 18 years and older.
- to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older.
- to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older.
BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective for other types of muscle spasms or for severe sweating anywhere other than your armpits.
IMPORTANT SAFETY INFORMATION
BOTOX® and BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® or BOTOX® Cosmetic:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing.
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® (onabotulinumtoxinA) has been used at the recommended dose to treat Chronic Migraine, severe underarm sweating, blepharospasm, or strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.
The dose of BOTOX® and BOTOX® Cosmetic are not the same as, or comparable to, another botulinum toxin product.
Serious and or immediate allergic reactions have been reported. These reactions include itchy rash, swelling, and shortness of breath. Tell your doctor or get medical help right away if you experience any such symptoms, further injection of BOTOX® or BOTOX® Cosmetic should be discontinued.
Do not take BOTOX® or BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® or BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® or Dysport™; have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® or BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including if you have: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (It is not known if BOTOX® or BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breastfeed (It is not known if BOTOX® or BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products.
BOTOX® and BOTOX® Cosmetic may cause loss of strength or general muscle weakness, or vision problems. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For more information on BOTOX® (onabotulinumtoxinA) or BOTOX® Cosmetic, please see the accompanying full Product Information, including Medication Guide.
Please see BOTOX® full Product Information, including Medication Guide.
Please see BOTOX® Cosmetic full Product Information, including Medication Guide.
Full Product Information, including Medication Guide has been provided to your doctor.
This press release contains "forward-looking statements," including the statements by Drs. Whitcup and Aurora, and other statements regarding the safety, effectiveness, approvals, adverse events and market potential of BOTOX® and BOTOX® Cosmetic. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning the above-referenced risk factors and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2009 Form 10-K and Form 10-Q for the quarter ended March 31, 2010. Copies of Allergan’s press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 714-246-4636.
About Allergan, Inc.
Allergan is a multi-specialty health care company established 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have more than 9,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics and medical devices, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, obesity, urologics, medical aesthetics and dermatology, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.
© 2010 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc.
Myobloc® is a registered trademark of Solstice Neurosciences, Inc.
Dysport™ is owned by Tercica, Inc., a subsidiary of the Ipsen Group
*Chronic migraine prevalence rates applied to 2010 US Population estimates for those 18+ years of age (n=234,504,070) (Source: CDC Wonder: http://wonder.cdc.gov/population-projections.html)
1 BOTOX [prescribing information]. Irvine, CA: Allergan, Inc.; 2010.
2 Diamond S, et al. Patterns Of Diagnosis And Acute And Preventive Treatment For Migraine In The United States: Results From The American Migraine Prevalence And Prevention Study. Headache. 2007;47:355-363.
3 Aurora SK, et al. OnabotulinumtoxinA For Treatment Of Chronic Migraine: Results From The Double-Blind, Randomized, Placebo-controlled Phase Of The PREEMPT 1 Trial. Cephalalgia. 2010;0(00):1-11. Available at http://cep.sagepub.com/content/30/7.toc. Last accessed September 8, 2010.
4 Natoli JL, et al. Global Prevalence of Chronic Migraine: A Systematic Review. Cephalalgia. 2010;30(5):599-609.
5 Jensen R, et al. Epidemiology And Comorbidity Of Headache. Lancet Neurol. 2008;7:354-361.
6 Harwood RH, et al. Current And Future Worldwide Prevalence Of Dependency, Its Relationship To Total Population, And Dependency Ratio. Bulletin of the World Health Organization. 2004;82(4):251-258.
7 Eross EJ. Chronic Migraine And Medication-Overuse Headache. Neurology. 2006;66:E43-E44.
8 Bigal ME, et al. Chronic Migraine in the Population. Neurology. 2008;71:559-566.
9 Deiner HC, et al. OnabotulinumtoxinA For Treatment Of Chronic Migraine: Results From The Double-Blind, Randomized, Placebo-Controlled Phase Of The PREEMPT 2 Trial. Cephalalgia. 2010;0(00):1–11. Available at http://cep.sagepub.com/content/30/7.toc. Last accessed September 8, 2010.
10 Allergan data on file; Medical Affairs
11 Allergan data on file; Global Regulatory Affairs
12 Allergan data on file; Global Literature & Information Services
Caroline Van Hove 714-246-5134 (media)
Crystal Muilenburg 714-246-5842 (media)
Jim Hindman 714-246-4636 (investors)
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Emil Schultz 714-246-4474 (investors)
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INDUSTRY KEYWORDS: Health Clinical Trials Pharmaceutical FDA