IRVINE, Calif., May 25 To address the low awareness and under-diagnosis of upper limb spasticity, Allergan, Inc., maker of BOTOX® (onabotulinumtoxinA), has joined forces with Henry Winkler and a coalition of five national patient advocacy organizations, including National Stroke Association, Brain Injury Association of America, National Spinal Cord Injury Association, United Cerebral Palsy and United Spinal Association, to launch the "Open Arms: Raising Awareness of Upper Limb Spasticity" educational campaign. Spasticity is a debilitating condition impacting approximately 1 million Americans, many of whom suffer from spasticity in the upper limbs following a stroke.(1) However, upper limb spasticity may also occur following a spinal cord or traumatic brain injury or in patients affected by multiple sclerosis or adults with a history of cerebral palsy.
See video from Allergan, Inc. at: http://inr.synapticdigital.com/OpenArms
The "Open Arms: Raising Awareness of Upper Limb Spasticity" educational campaign aims to reach those who are impacted by upper limb spasticity and don't know where to turn for help. At www.OpenArmsCampaign.com, those affected by upper limb spasticity will learn how to recognize the condition and find resources to help locate a neurologist or physiatrist that is trained to manage and treat the condition. Throughout the year, several educational seminars will be hosted in cities across the country, as well as on the Internet.
Tightness or stiffness in the upper limb significantly hinders a person's ability to perform everyday activities, like getting dressed, hygiene and eating. A person dealing with upper limb spasticity may present with a clenched hand in a tight, balled up fist, an arm that is pinned tightly against the chest or a flexed elbow or wrist that cannot be straightened without discomfort and force. Unfortunately, the condition often goes undiagnosed because it may onset weeks, months or even years after the original injury - after the patient is discharged from the hospital and is no longer seeing a specialist familiar with and specifically trained to treat the condition.
Legendary "Happy Days" star Henry Winkler, is personally familiar with the impact that upper limb spasticity can have on a person. His late mother struggled with the condition, without treatment, for 10 years following a stroke before she passed away.
"My mother was a proud woman, a busy bee, always on the go. So, it was very difficult for me to watch her revert inward as she was less and less able to do things for herself. She became fully dependent on her family and live-in nurses to help her with simple, ordinary tasks we all take for granted," Mr. Winkler recalls. "Much less was known about upper limb spasticity during her time, and now, not only do we know more about how to manage this condition, there are treatment options available. Whether you are just starting to experience what you think could be upper limb spasticity, or you've been living silently with it for years, the message is that there are treatment options and you should talk to a doctor."
To help with the management of upper limb spasticity, the FDA recently approved BOTOX® (onabotulinumtoxinA) as the first and only botulinum toxin for the treatment of increased muscle stiffness in the elbow, wrist and finger muscles in adults with upper limb spasticity. While not a cure for upper limb spasticity, BOTOX® may allow people living with upper limb spasticity to once again be able to open the affected hand or arm, which may allow the person to regain some independence.
"It's critical for someone who suspects they may be experiencing upper limb spasticity to seek consultation from a physician specifically trained to treat upper limb spasticity. Often, even if the person has been suffering with the condition for years, there are ways we can help manage their condition effectively so the person can have a little bit easier time with daily activities," says Allison Brashear, M.D., a clinical neurologist at Wake Forest University School of Medicine, Winston-Salem, NC. "With the recent FDA approval of BOTOX®, physicians now have a new treatment in their toolbox, which is good news for people living with upper limb spasticity."
For more information about upper limb spasticity, or to find a neurologist or physiatrist who treats the condition, please visit www.OpenArmsCampaign.com or the official campaign page on Facebook (Facebook.com/openarmscampaign).
BOTOX® (onabotulinumtoxinA) Important Information
BOTOX® is a prescription medicine that is injected into muscles and used:
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.
It is not known whether BOTOX® is safe or effective for other types of muscle spasms or for severe sweating anywhere other than your armpits.
Important Safety Information
BOTOX® 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®:
Important Safety Information (continued)
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat severe underarm sweating, blepharospasm, or strabismus.
The dose of BOTOX® is 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® should be discontinued.
Do not take BOTOX® if you: are allergic to any of the ingredients in BOTOX® (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®.
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® can harm your unborn baby); are breast-feeding or plan to breastfeed (It is not known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products.
BOTOX® 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® 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®, please see the accompanying BOTOX® full Product Information, including Medication Guide.
About Allergan, Inc.
Allergan, Inc. 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 8,000 highly dedicated and talented employees living 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.
This press release contains "forward-looking statements," including the statements by Dr. Brashear and Mr. Winkler, and other statements regarding the safety, effectiveness, adverse reactions, and market potential of BOTOX®. 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 these 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 Allergan's Form 10-Q for the quarter ended March 31, 2010. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.Allergan.com or you can contact the Allergan Investor Relations department by calling (714) 246-4636.
© 2010 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc.
Dysport® is a registered trademark of Ipsen Biopharm Limited
Myobloc® is a registered trademark of Solstice Neurosciences, Inc.
Registered journalists can access video, audio, text, graphics and photos at http://www.thenewsmarket.com.
(1) Allergan Data on File; Global Literature & Information Services
-- 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.
SOURCE Synaptic Digital; Allergan, Inc.