Aug 12, 2017

Botox for Spasticity Didn't Work? Try Dysport If You Like



This article caught my eye: Ibsen Pharmaceuticals developed a drug for spasticity--Dysport. Huh! I thought the only drug in the world to stop spasticity was BOTOX. (Maybe all caps the way BOTOX is often written swayed my opinion).

Anyway, the US Food and Drug Administration (FDA) recently approved the use of Dysport for the treatment of upper and lower limb spasticity to reduce the spasms in adult patients and only lower limb spasticity in children under 18. (Physical and occupational therapists call it tone, but everybody has tone. What therapists are really saying is abnormal tone, resulting in spasms or spasticity).

Clinical improvement with Dysport can happen after a week, with duration in improvement as long as 20 weeks before another injection is needed. Dysport can be used for spasticity in stroke patients and well as other traumatic brain injuries.

Cynthia Schwalm, Chief Executive Officer, Ipsen Biopharmaceuticals, Inc. says, “Spasticity can have a profound impact on adult patients and their abilities to perform the most basic daily tasks. Ipsen is committed to providing these patients, their caregivers and physicians with a comprehensive support offering including Dysport."

The FDA approval was based in part on clinical trials conducted in over 600 patients. The medicine was first registered in the United Kingdom in 1990 for other uses and is licensed in more than 80 countries in eight different indications, with over 1,300 peer-reviewed publications.

Known as the Phase III pivotal study, 238 adult patients with required upper limb spasticity participated in the study for up to one year. The Phase III data showed that those treated with Dysport demonstrated statistically significant improvement in muscle tone measured by the Modified Ashworth Scale (MAS), the scale originally used to test multiple sclerosis patients. 

"At Week 4," the report says, "both doses of Dysport  (500 units and 1000 units) significantly reduced muscle tone as measured by MAS in all primary target muscle groups,,,with approximately 3 out of 4 patients responding to Dysport. The most frequently reported adverse reactions (≥2%) are urinary tract infection, nasopharyngitis, muscular weakness, musculoskeletal pain, dizziness, fall and depression." (No comparison with Botox was accomplished drug-to-drug in any of the studies, but Botox has mostly the same adverse side effects).

Spasms for me go on for as much as two hours in a row, every 18 seconds, even now, 8 years after my stroke. When I had Botox injected in my leg 2 years after the stroke, I felt little relief, and that relief was short-lived. I was injected twice by the same doctor. When time 3 occurred, I couldn't get an appointment and had to see another doctor in the same facility. I always had the same questions, but when I asked the new doctor if Botox was dangerous, he said, "You could die." I jumped off the table, headed for the door, and left, but he was right.

"Dysport and all botulinum toxin products," the report goes on to say, "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." (Gulp!)

If you do try Dysport, report any negative side effects of the drug or, for that matter, any prescription drugs to the FDA. (Doctors get free pills or injections from the drug companies known as samples, so you can't depend on the docs to report side effects. The docs are "wined and dined" by the drug companies to get the docs to prescribe their product. The drug companies and the docs have a co-dependency and you are a virtual guinea pig. So you have to be your own advocate). Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.