Dysport Therapeutic Approved by Health Canada for Lower Limb Spasticity Treatment in Adults

Dysport Therapeutic Approved by Health Canada for Lower Limb Spasticity Treatment in Adults

AbobotulinumtoxinA, marketed as Dysport Therapeutic by Ipsen Biopharmaceuticals Canada, was approved by Health Canada for the treatment of lower limb focal spasticity in adults.

Focal spasticity is a medical disorder characterized by an abnormal increase in muscular stiffness in one or more muscles, and usually is the result of a brain or spinal cord injury. Such injury may affect movement control and impair daily activities. Spasticity may be linked to multiple sclerosis, cerebral palsy, spinal cord injury, stroke, and brain or head trauma.

The degree of spasticity ranges from mild muscle stiffness to severe, painful and uncontrollable muscle spasms. In the lower limbs, spasticity usually occurs in the gastrocnemius and soleus muscle complex located in the calf. These calf muscles are responsible for walking by raising the heel from the ground.

Increased muscle tone, exaggerated deep tendon reflexes, rapid muscle contractions and/or muscle spasms are some of the clinical symptoms associated with spasticity.

Dysport Therapeutic consists of an injectable form of botulinum toxin type A (BoNT-A), a molecule produced by Clostridium bacteria. Dysport blocks overactive nerve signals, causing contracted muscles to relax.

Positive results from a Phase 3 clinical trial, including 385 patients with lower limb spasticity, dictated Dysport Therapeutic’s regulatory approval.

Patients were randomized to receive Dysport 1,000 units (125 patients), 1,500 units (128 patients), and placebo (128 patients) via intramuscular injection into the gastrocnemius-soleus muscle complex.

Muscle tone was assessed by the Modified Ashworth Scale (MAS) test at the ankle joint (with the knee extended) at week four of treatment.

Mean changes in MAS in the gastrocnemius-soleus muscle complex from day 0 were -0.5 in the placebo group, -0.6 in the Dysport 1,000 units group, and -0.8 in the Dysport 1,500 units group.

Results showed that Dysport 1,500 units injection improved muscle tone and spasticity at the ankle joint at week four. Treatment response lasted 12–16 weeks in most of the patients.

Adverse reactions were registered, and the most prevalent were falls, muscular weakness and myalgia (muscle pain).

“In addition to rehabilitation, botulinum neurotoxin medication represents an important intervention in helping patients impacted by lower limb spasticity move towards improving their function and ultimately their quality-of-life”, Theodore Wein, MD, said in a press release. Wein is assistant professor of Neurology and Neurosurgery, Stroke Prevention Clinic, Montreal General Hospital, Quebec.

Dysport already is approved in the U.S. as a therapy for lower limb spasticity in adults.

“The Health Canada approval represents an important milestone for our company. Dysport now has the broadest spasticity label in Canada among the botulinum neurotoxins, which are critical in managing disabling motor disorders. The approved indications of adult upper and lower limb spasticity and pediatric lower limb spasticity underscore Ipsen’s commitment to patients and the motor disorders community at large,” said Paul Reider, general manager for Ipsen Biopharmaceuticals Canada.

 

 

5 comments

  1. WW says:

    This is why the Mational MS Society is a failure and a hindrance to a cure, not a facilitator. They WASTE money on crap like this then claim theres no $$$ for studies that actually lead to a cure. It’s also why they dont get a penny from me or those who know me. Let’s see if they allow this post.

    • John Rush says:

      I am not affiliated with any MS Society any way other than volunteering to walk/ walks for them to raise funds. Regarding your concerns over their research, and not giving them money, are you referring to Europe, Canada, or USA projects? Also, are you concerned that the funding is not towards direct research into a “cure” vs other projects such a medicine to improve a symptom?
      Here is some of the NMSS of funding in US:

      https://www.nationalmssociety.org/Research/Research-We-Fund/Past-Research-Efforts

      This is what Canada funded recently: https://mssociety.ca/library/document/u9L0NQ1jzVk6MqcnpiBvPr38xR4d5ElU/original.pdf

      Of course, you are free to spend your funds how you see fit, but it does appear they fund many studies in areas not just improving disease symptoms like this spasticity drug, but also in areas of preventing progression as well as some funded research into rymyelination.

      It is frustrating how long the studies take, but I believe there is value to fund such things as recruiting neurologists to fellowship work in MS, etc – other areas the MS societies spend money that, still, indirectly impacts work towards a cure. If you want to help fund efforts for MS I am not sure where else to donate directly – perhaps a local hospital’s research fund? Best, J

    • Mark D says:

      But how have they wasted money on “crap like this”? Health Canada has chosen to approve it, the approval has nothing to do with funding either by the “MS Society” nor anyone else. Any decision whether or not to fund it comes later.

    • Mary-Jane says:

      I am sorry the m.s. funds and not doing anything you want fast enough, let me tell you about what the do for me the 7,853.25 dollars it cost for the drugs that help the patient pay for their dugs, my coypaments are 20 % of that amount is 280.00. If they did not raise money I wouldn’t have the money for my medicine along with that med I have to take 6 other meds to try to have quality of life and I have had m.s. my entire adult life, I am 50 yrs old when I got my news I was 21 just had had I baby and did not know what m.s was I take all the help I can. Thanks for your opinion.

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