Sunovion Pharmaceuticals gets USFDA nod for KYNMOBI for Parkinson's disease off episodes

KYNMOBI dissolves under the tongue to help people with PD improve their OFF symptoms as needed

Published On 2020-05-24 04:30 GMT   |   Update On 2021-08-20 11:30 GMT
Advertisement

Marlborough: Sunovion Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved KYNMOBI™ (apomorphine HCI) sublingual film (APL-130277) 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 in the morning upon waking and throughout the day.

Advertisement

KYNMOBI dissolves under the tongue to help people with PD improve their OFF symptoms as needed.

"Today's approval of KYNMOBI advances treatment options for people with Parkinson's disease who experience OFF episodes and the associated disruption of everyday activities," said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. "We are pleased to offer the Parkinson's disease community a novel treatment option that we believe offers a convenient way for patients to rapidly improve impaired movements and better control their motor symptoms when they need it."

Parkinson's disease is a chronic neurodegenerative disease in which dopamine-producing cells are lost. It is projected that 1.2 million Americans will be living with PD by 2030. Within the first four to six years after diagnosis, regardless of disease severity, up to 60 per cent of people with PD experience OFF episodes.

"Several years after a person is diagnosed with Parkinson's disease they may notice problems such as having trouble getting out of bed in the morning or having difficulty getting out of a chair, or that they feel frozen while trying to walk as the effect of their maintenance medication diminishes," said Stewart Factor, D.O., Professor of Neurology, Director of the Movement Disorders Program and Vance Lanier Chair of Neurology at Emory University School of Medicine. "The approval of KYNMOBI affords health care providers with a needed option that can be added to their patients' medication regimen to adequately address OFF episodes as their Parkinson's disease progresses."

"We know from our research and discussions with the Parkinson's community that OFF episodes can significantly disrupt a patient's daily life," said Todd Sherer, Ph.D., CEO, The Michael J. Fox Foundation for Parkinson's Research. "The Foundation supported early clinical development of sublingual apomorphine, and this approval brings an important new treatment option for people with PD who experience OFF."

Read also: Lupin gets USFDA nod for Trientine Hydrochloride Capsules

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News