Sunovion gets FDA nod for KYNMOBI™ as Parkinson’s Disease treatment

Sunovion has announced it has received approval from the FDA for KYNMOBI™ (apomorphine hydrochloride) Sublingual Film for the treatment of Parkinson’s Disease OFF Episodes.

Sunovion Pharmaceuticals Inc. 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).

Antony Loebel, M.D., President and CEO at Sunovion:

“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”. “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.”

About KYNMOBI™ (apomorphine hydrochloride)

KYNMOBI (apomorphine hydrochloride) sublingual film is a prescription medicine used to treat short-term (acute), intermittent “OFF” episodes in people with Parkinson’s disease (PD). The medicine, is a dopamine agonist, a novel formulation of apomorphine, and the first and only sublingual therapy for the fast-acting, on-demand treatment of OFF episodes associated with Parkinson’s disease which can be administered up to five times a day if needed.

The findings of Phase 3 clinical studies published in Lancet Neurology revealed that patients with PD undergoing KYNMOBI reported substantial improvement in motion symptoms at week 12 just 30 minutes after dosing with an overall decrease of 7.6 points versus placebo estimated on the (MDS-UPDRS) of the Movement Disorder Society Unified Parkinson. diseases Rating scale. Nausea, oropharyngeal reactions, somnolence and dizziness were among the most commonly reported adverse effects in this trial (observed in more than 5 percent of patients and at a rate greater than placebo).

Parkinson’s Disease OFF Episodes

OFF episodes are the re-emergence or exacerbation of otherwise controlled PD symptoms with oral levodopa/carbidopa. These can be identified by tremor, trembling, slow motion or other symptoms. Such destructive episodes will occur during the day and in the morning after awakening. KYNMOBI dissolves under the tongue to help people with PD relieve the effects of OFF when appropriate.

Parkinson’s disease is a chronic neurodegenerative condition in which cells producing dopamine are lost. Latest statistics predict that 1.2 million Americans and 10 million globally will be living with PD by 2030. Within the first four to six years after diagnosis, up to 60 percent of people with PD experience OFF episodes, irrespective of the severity of the disease.

Stewart Factor, D.O., Professor of Neurology, Director of the Movement Disorders Program and Vance Lanier Chair of Neurology at the Emory University School of Medicine said:

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.”

“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.”

Todd Sherer, Ph.D., CEO, The Michael J. Fox Foundation for Parkinson’s Research said:

“We know from our research and discussions with the Parkinson’s community that OFF episodes can significantly disrupt a patient’s daily life.”

“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.”

Sunovion aims for KYNMOBI to be available in US pharmacies as of September this year.

About Sunovion Pharmaceuticals Inc.

Sunovion is a multinational biopharmaceutical corporation focused on integrating research and novel medicine to support patients with severe medical conditions. The vision of Sunovion is to guide the way into a healthier world. The creative spirit of the organisation is motivated by the belief that by joining scientific excellence with efficient advocacy and relevant education, will benefit lives. With patients at the forefront of what it does, Sunovion has set out innovative pathways to life-transforming therapies that embody significant investment in research and technology efforts and an unwavering dedication to helping individuals with psychiatric , neurological, and respiratory disorders.

Sunovion, headquartered in Marlborough, Mass., is an indirect wholly-owned, partial subsidiary of Sumitomo Dainippon Pharma Co., Ltd. The wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. are Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., headquartered in Mississauga, Ont.

Additional information can be found on the company’s websites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is one of Japan’s top-ten listed pharmaceutical companies trading internationally in major pharmaceutical markets, comprising Japan, the U.S., China and the EU. Sumitomo Dainippon Pharma plans to develop groundbreaking medicinal products that have been approved in the Psychiatry & Neurology, Oncology and Regenerative Medicine / Cell Therapy which have been designated
It is based on the 2005 merger between Dainippon Pharmaceutical Co., Ltd. and Sumitomo Pharmaceuticals Co. , Ltd. Sumitomo Dainippon Pharma currently employs more than 6,000 people worldwide.

Further information about Sumitomo Dainippon Pharma can be found on its corporate website at www.ds-pharma.com.

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