(BPT) - Currently the ONLY botulinum toxin approved by the FDA for the treatment of upper and lower limb spasticity in adults and also for the treatment of lower limb spasticity in children ages two and older
Spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness in one or more muscles, which might interfere with movement. The spasticity is usually caused by damage to nerve pathways in the brain or spinal cord that control muscle movement.1 In adults, approximately one in three stroke patients, one in three patients with spinal cord injury, one in six patients with traumatic brain injury, and two in three patients with Multiple Sclerosis (MS) will develop lower limb spasticity.2,3 Adult patients with Cerebral Palsy (CP) also commonly experience spasticity in their lower limbs.2
'Adults who have developed spasticity as a result of a stroke, Multiple Sclerosis, Cerebral Palsy, spinal cord injury, or traumatic brain injury now have another option when seeking treatment that helps reduce the effects of the increased muscle tone in their lower extremities,' said Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen.
The U.S. Food and Drug Administration (FDA) has expanded the approved use of Dysport® (abobotulinumtoxinA) for injection for the treatment of spasticity in adults, based on the supplemental Biologics License Application (sBLA) in lower limb spasticity submitted by Ipsen Biopharmaceuticals, Inc. This approval marks the second FDA approval for Dysport® in less than one year. In July 2016, Dysport® was approved to treat pediatric patients with lower limb spasticity aged two and older, making it the first and only botulinum toxin approved for this indication.
'We are proud that Dysport® is now available to support an additional population of patients- including those adults managing their spasticity associated with stroke, spinal cord injury, brain injury, Multiple Sclerosis, or Cerebral Palsy- and that Ipsen is able to provide comprehensive support offerings, including the IPSEN CARES® patient assistance program and the C.L.I.M.B.® injector training platform for healthcare providers.' said Cynthia Schwalm, President, North America Commercial Operations, Ipsen.
Dysport® and all botulinum toxins have a Boxed Warning which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. Dysport® should not be used in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components; or in the presence of infection at the proposed injection site(s); or in patients known to be allergic to cow's milk protein. Hypersensitivity reactions including anaphylaxis have been reported. The potency Units of Dysport® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products. Please see below for additional Important Safety Information.
The approval is based on a Phase III, multi-center, prospective, double-blind, randomized placebo-controlled study, in which adult patients treated with Dysport® following a stroke or traumatic brain injury showed improvement in muscle tone at the ankle joint, measured by the LS mean change from baseline on the Modified Ashworth Scale (MAS) at Week 4. The duration of response for the majority of patients within the study was between 12-16 weeks. In this study, some patients experienced a longer duration of response (approximately 20 weeks). The degree and pattern of muscle at the time of re-injection may necessitate alterations in the dose of Dysport® and muscles to be injected. Repeat Dysport® treatment should be administered when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection.
What is Dysport®?
Dysport® is a prescription medicine that is injected into muscles and used to treat:
- increased muscle stiffness in adults with spasticity
- cervical dystonia (CD) in adults
- increased muscle stiffness in children 2 years of age and older with lower limb spasticity
It is not known whether Dysport® is safe or effective in children under 2 years old for the treatment of lower limb spasticity.
It is not known whether Dysport® is safe or effective for the treatment of other types of muscle spasms.
It is not known whether Dysport® is safe or effective for the treatment cervical dystonia or upper limb spasticity in children under 18 years of age.
Important Safety Information for Dysport®
Dysport® (abobotulinumtoxinA) may cause serious side effects that can be life threatening, including problems breathing or swallowing, and spread of toxin effects. These problems can happen within hours, or days to weeks after an injection of Dysport®. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with Dysport®. Call your doctor or get medical help right away if you have any of these problems after treatment with Dysport®:
- Problems swallowing, speaking, or breathing after an injection of Dysport® if the muscles that you use to breathe or swallow become weak. If these problems are severe, death can happen as a complication. People with certain breathing problems may need to use muscles in their necks to help them breathe and may be at greater risk for serious breathing problems with Dysport®.
- Swallowing problems may last for several weeks; you may need a feeding tube to receive food or water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving Dysport® have the highest risk of getting these problems.
Spread of toxin effects. In some cases, the effects of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, or trouble swallowing. These problems could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.
Do not take Dysport® if you are allergic to Dysport® or any of the ingredients in Dysport® (See Medication Guide for ingredients), or are allergic to cow's milk protein; had an allergic reaction to any other botulinum toxin product, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); or have a skin infection at the planned injection site.
Before you take Dysport®, tell your doctor about all your medical conditions, including if you have a disease that affects your muscles and nerves (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 difficulty swallowing or breathing.
Before you take Dysport®, tell your doctor if you have or have had any of the following: a side effect from any botulinum toxin in the past; breathing problems such as asthma or emphysema; swallowing problems; bleeding problems; diabetes; and slow heartbeat, or other problems with your heart rate or rhythm.
Tell your doctor if you have plans to have surgery, had surgery on your face, have weakness of your forehead muscles (such as trouble raising your eyebrows), have drooping eyelids, or have any other change in the way your face normally looks.
Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding or planning to breast-feed. It is not known if Dysport® can harm your unborn baby. It is not known if Dysport® passes into breast milk.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received Dysport® in the past.
Especially tell your doctor if you have received injections of botulinum toxin in the last four months or in the past. Be sure your doctor knows exactly which product you received such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; or take a sleep medicine.
Most common side effects of Dysport® in adults with upper limb spasticity include: urinary tract infection, muscle weakness, musculoskeletal pain, fall, depression, stuffy or runny nose and sore throat, and dizziness.
Most common side effects of Dysport® in adults with lower limb spasticity include: muscle weakness, pain in your arms or legs, and fall.
Most common side effects of Dysport® in people with cervical dystonia include: muscle weakness, dry mouth, feeling of tiredness, muscle pain, problems speaking, eye problems, difficulty swallowing, injection site pain, and headache.
Most common side effects of Dysport® in children (2 to 17 years of age) with lower limb spasticity include: upper respiratory infection, stuffy or runny nose and sore throat, flu, cough, and fever.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Dysport®. For more information, ask your doctor or pharmacist.
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.
Please see Dysport® Full Prescribing Information including Boxed Warning and Medication Guide.
Botox®, Xeomin®, and Myobloc® are registered trademarks of their respective owners.
- National Institute of Neurological Disorders and Stroke. Spasticity Information Page. https://www.ninds.nih.gov/Disorders/All-Disorders/Spasticity-Information-Page Accessed May 16, 2017.
- Martin A, et al. Epidemiological, humanistic, and economic burden of illness of lower limb spasticity in adults: a systematic review. Neuropsychiatric Disease and Treatment. 2014; 10 (111-122)
- Sköld A, et al. Spasticity after traumatic spinal cord injury: nature, severity, and location. Archives of Physical Medicine and Rehabilition. 1999; 80 (1548-57)
Dysport® (abobotulinumtoxinA) for injection, for intramuscular use 300- and 500-Unit vials.
DYSPORT and C.L.I.M.B. are registered trademarks of Ipsen Biopharm Limited.
IPSEN CARES is a registered trademark of Ipsen S.A.
2017 Ipsen Biopharmaceuticals, Inc.
June 2017 DYS-US-001853