Onstryv Now Approved for Parkinson’s Patients in Canada

Onstryv Now Approved for Parkinson’s Patients in Canada

Onstryv (safinamide) has been approved for the treatment of Parkinson’s disease in Canada, where roughly 100,000 individuals live with the disorder.

The announcement was made by Quebec-based Valeo Pharma and Italian pharmaceutical conglomerate Zambon, the commercialization partner of Newron Pharmaceuticals, a biopharmaceutical company focused on the development of therapies for diseases of the central and peripheral nervous system.

The agreement with Zambon calls for Valeo Pharma, a specialty pharmaceutical company dedicated to commercializing innovative prescription products, to be responsible for all regulatory requirements, quality, sales and marketing, and drug distribution. Onstryv is expected to be available in Canada by June.

”The approval of safinamide in Canada is a step forward for patients who need new treatment options for Parkinson’s disease,” Roberto Tascione, Zambon’s CEO, said in the press release. “Our mission is to make this medication available to as many [Parkinson’s disease] patients worldwide as possible.”

Known as Onstryv in Canada and Xadago in the rest of the world, this compound is an oral, once-a-day, add-on therapy developed by Newron, and approved in the United States in March 2017 by the U.S. Food and Drug Administration to improve motor function in Parkinson’s patients who experience “off periods” while on treatment with levodopa and/or Lodosyn (carbidopa).

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While partially effective, therapy using either or both levodopa and carbidopa results in debilitating fluctuations between a state of normal motor function (known as “on episodes”) and reduced motor function (“off periods”) as the treatment’s effectiveness wears off. What’s more, the increased doses necessary as the disease progresses frequently cause uncontrolled involuntary movements, a condition known as dyskinesia.

Onstryv raises the level and function of dopamine in the brain, both through the reversible blockage of the enzyme monoamine oxidase B that normally breaks down this chemical, and by inhibiting transporters responsible for its absorption and retention. In addition, the medicine inhibits the excessive release of the signaling molecule glutamate.

Following four randomized, double-blind, placebo-controlled Phase 3 trials, published results indicated that the addition of Onstryv increased the frequency of on episodes, decreased off periods, and improved motor function in levodopa-treated patients.

In 2017, Valeo and Zambon announced a partnership granting Valeo exclusive Canadian rights to commercialize Onstryv. In addition to Canada and the U.S., the medicine is approved in the European Union and Switzerland and was recently approved in Australia.

“There is a growing need for new treatments to manage Parkinson’s disease, and Onstryv provides an important option for patients that require better control of their symptoms,” said Steve Saviuk, Valeo’s CEO. “We look  forward to launching the first new oral treatment for Parkinson’s disease in over a decade to Canadian patients in need of a new therapeutic choice.”

In recent related news, a review study found that, along with cannabinoids and opioids, Onstryv may relieve Parkinson’s patients’ pain, a frequent non-motor symptom.

Mary M. Chapman began her professional career at United Press International, running both print and broadcast desks. She then became a Michigan correspondent for what is now Bloomberg BNA, where she mainly covered the automotive industry plus legal, tax and regulatory issues. A member of the Automotive Press Association and one of a relatively small number of women on the car beat, Chapman has discussed the automotive industry multiple times of National Public Radio, and in 2014 was selected as an honorary judge at the prestigious Cobble Beach Concours d’Elegance. She has written for numerous national outlets including Time, People, Al-Jazeera America, Fortune, Daily Beast, MSN.com, Newsweek, The Detroit News and Detroit Free Press. The winner of the Society of Professional Journalists award for outstanding reporting, Chapman has had dozens of articles in The New York Times, including two on the coveted front page. She has completed a manuscript about centenarian car enthusiast Margaret Dunning, titled “Belle of the Concours.”
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Mary M. Chapman began her professional career at United Press International, running both print and broadcast desks. She then became a Michigan correspondent for what is now Bloomberg BNA, where she mainly covered the automotive industry plus legal, tax and regulatory issues. A member of the Automotive Press Association and one of a relatively small number of women on the car beat, Chapman has discussed the automotive industry multiple times of National Public Radio, and in 2014 was selected as an honorary judge at the prestigious Cobble Beach Concours d’Elegance. She has written for numerous national outlets including Time, People, Al-Jazeera America, Fortune, Daily Beast, MSN.com, Newsweek, The Detroit News and Detroit Free Press. The winner of the Society of Professional Journalists award for outstanding reporting, Chapman has had dozens of articles in The New York Times, including two on the coveted front page. She has completed a manuscript about centenarian car enthusiast Margaret Dunning, titled “Belle of the Concours.”
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