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Sunovion Pharmaceuticals Inc. announced that Health Canada has approved KYNMOBI soluble film for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD). OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. They may be characterized, in part, by tremor, stiffness, slowed movement or other symptoms. These disruptive episodes can occur any time throughout the day and get worse as the disease progresses. KYNMOBI was previously approved by the U.S. Food and Drug Administration (FDA) on May 21, 2020.
“The unpredictable and frequent nature of OFF episodes, which can occur despite people taking their oral maintenance medications as prescribed, makes this a particularly challenging and burdensome facet of Parkinson’s disease,” said Anthony E. Lang, M.D., Professor at University of Toronto and Jack Clark Chair for Parkinson’s Disease Research, and Director of the Edmond J Safra Program in Parkinson’s disease at Toronto Western Hospital. “KYNMOBI is a welcome on-demand treatment that physicians can offer patients to help rapidly improve their PD OFF episodes.”
Parkinson’s disease is a chronic neurodegenerative disease in which dopamine producing cells are lost. Approximately 94,000 Canadians are living with Parkinson’s disease, and this is expected to increase by an estimated 50 percent by 2031.1 Within the first four to six years after diagnosis, regardless of disease severity, up to 60 percent of people with PD experience OFF episodes.2 These OFF episodes can happen in the morning, upon waking, around timed medication doses, and unpredictably throughout the day. OFF episodes may also cause anxiety and depressive symptoms in some people with PD.3
“As the disease progresses patients with Parkinson’s are faced with challenging and disruptive OFF episodes that come with impaired mobility,” said Karen Lee, PhD, CEO of Parkinson Canada. “Today’s Health Canada approval is an important step forward for people living with Parkinson’s disease, as they now have more options that can help manage the effects of OFF episodes as they occur.”
“OFF episodes disrupt the daily lives of people living with Parkinson’s disease as well as their care partners and can make simple tasks like getting ready in the morning or buttoning a shirt extremely difficult,” said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. “The Health Canada approval of KYNMOBI provides healthcare providers and people living with Parkinson’s disease with a novel treatment option that allows a quick and reliable transition from OFF to ON so they can more easily function in their daily lives.”
Sunovion is working to make KYNMOBI available in pharmacies across the Canadian provinces as quickly as possible.
About Sunovion Pharmaceuticals Inc.
Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the onviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions.
Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion Pharmaceuticals Europe Ltd., based in London, England, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
