Sunovion Announces U.S. FDA Approval of KYNMOBI™ (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes

- First and only sublingual therapy approved for the on-demand treatment of Parkinson’s disease OFF episodes -

- In a Phase 3 study, patients with Parkinson’s disease treated with KYNMOBI experienced significant improvements in motor symptoms at 30 minutes, compared to placebo -

MARLBOROUGH, MA, USA I May 21, 2020 ISunovion Pharmaceuticals Inc. (Sunovion) announced today 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. 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 2030.1 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

“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.”

Sunovion expects KYNMOBI to be available in U.S. pharmacies in September 2020.

Medical information, patient assistance and other information about KYNMOBI can be obtained by calling Sunovion Answers at 1-844-596-6624 (844-KYNMOBI) Monday through Friday from 8:00 a.m. to 8:00 p.m. ET.

ABOUT KYNMOBI™

KYNMOBI (apomorphine hydrochloride) sublingual film, a novel formulation of apomorphine, a dopamine agonist, is the first and only sublingual therapy for the fast-acting, on-demand treatment of OFF episodes associated with Parkinson’s disease. KYNMOBI may be used up to five times a day.

Phase 3 clinical trial results, published in Lancet Neurology, demonstrated that patients with PD receiving KYNMOBI experienced significant improvements in motor symptoms at 30 minutes after dosing at week 12, with a mean reduction of 7.6 points, compared to placebo, on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. Initial clinical improvements were seen at 15 minutes post-administration. Additionally, a significantly higher percentage of people treated with KYNMOBI had a patient-rated full ON response within 30 minutes at week 12, compared with people receiving placebo. KYNMOBI was generally well-tolerated. Among the most frequently reported treatment-emergent adverse events in this study (occurring in more than 5 percent of patients and at a rate greater than placebo) were nausea, oropharyngeal reactions, somnolence and dizziness.

Important Safety Information

INDICATION

KYNMOBITM (apomorphine hydrochloride) sublingual film is a prescription medicine used to treat short-term (acute), intermittent “off” episodes in people with Parkinson’s disease (PD).

About Parkinson’s Disease and OFF Episodes

By 2030, it is estimated that 1.2 million people in the U.S. and an estimated 10 million people worldwide will be living with Parkinson’s disease (PD).1 PD is a chronic, progressive neurodegenerative disease characterized by motor symptoms, including tremor at rest, rigidity and impaired movement, as well as significant non-motor symptoms, including cognitive impairment and mood disorders. It is the second most common neurodegenerative disease after Alzheimer’s disease3, and the prevalence of PD is increasing as the world’s population ages.

OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. These episodes may disrupt a person’s ability to perform everyday activities, can cause anxiety and may be burdensome for patients, family and care partners. OFF episodes are experienced by nearly 60 percent of people with PD within the first four to six years of diagnosis, and may worsen in frequency and severity over the course of the illness.2

About Sunovion Pharmaceuticals Inc. (Sunovion)

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 conviction 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 Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s websites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.

KYNMOBI and are trademarks of Sunovion Pharmaceuticals Inc.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.

© 2020 Sunovion Pharmaceuticals Inc. All rights reserved.

For a copy of this release, visit Sunovion’s web site at www.sunovion.com

References

1 Parkinson’s Disease Foundation Website: https://www.parkinson.org/about-us/Press-Room/Press-Releases/New-Study-Shows-Over-1-Million-People-in-the-United-States-Estimated-to-be-Living-with-Parkinsons-Disease-by-2030. Accessed May 2020.
2 Schrag, A. “Dyskinesias and motor fluctuations in Parkinson's disease: A community-based study.” Brain. November 2000, Vol. 123, Issue 11. p. 2297-2305. Available online: https://academic.oup.com/brain/article/123/11/2297/256050. Accessed May 2020.
3 Lebouvier, T., Chaumette, T., Paillusson, S., Duyckaerts, C., des Varannes, S. B., Neunlist, M., & Derkinderen, P. (2009). The second brain and Parkinson's disease. European Journal of Neuroscience, 30(5), 735–741. Available online: https://doi.org/10.1111/j.1460-9568.2009.06873.x. Accessed May 2020.

SOURCE: Sunovion Pharmaceuticals

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