MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) announced today that Health Canada has accepted the New Drug Submission (NDS) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes), experienced by people living with Parkinson’s disease (PD), including those who experience early morning OFF episodes.
OFF episodes can cause severe disruption for someone living with PD, often causing a major disturbance in a person’s ability to maintain everyday activities. While OFF episodes are experienced by 40 to 60 percent of all people living with PD, there are limited on-demand treatment options available.1
“Few options are available for the treatment of motor fluctuations which are commonly experienced by patients with Parkinson’s disease,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “We look forward to working with Health Canada to bring apomorphine sublingual film to patients with OFF episodes and Parkinson’s disease in Canada.”
Apomorphine sublingual film is being developed as a fast-acting medicine for the on-demand treatment of all types of OFF episodes, including morning OFF, unpredictable OFF and end-of-dose wearing OFF.
About Apomorphine Sublingual Film (APL-130277)
Apomorphine
sublingual film (APL-130277), a novel formulation of apomorphine, a
non-ergot dopamine agonist, is being developed as a fast-acting
sublingual film for the on-demand management of OFF episodes associated
with Parkinson’s disease (PD). Apomorphine is the only agent approved
for the acute, intermittent treatment of hypomobility, “OFF” episodes
(“end-of-dose wearing OFF” and unpredictable “ON/OFF” episodes)
associated with advanced PD, and in Canada and the U.S. it is currently
approved as a subcutaneous injection. Apomorphine sublingual film is
intended to rapidly convert people living with PD from an OFF to an ON
state and has been studied for the treatment of OFF episodes up to five
times per day. Sunovion announced the U.S. Food and Drug Administration
accepted its New Drug Application submission for apomorphine sublingual
film on June 12, 2018. Apomorphine sublingual film has not been approved
by Health Canada. In October 2016, Sunovion acquired Cynapsus
Therapeutics Inc. (Canadian Specialty Central Nervous System
Biotechnology Company), along with its product candidate APL-130277. The
Michael J. Fox Foundation for Parkinson’s Research funded in part two
Phase I trials of APL-130277 – a comparative
biostudy in healthy volunteers and a dosing
study in people with Parkinson's disease.
About Parkinson’s Disease and OFF Episodes
An estimated four
to six million people worldwide live with Parkinson’s disease (PD). 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 behind Alzheimer’s disease, and the prevalence
of PD is increasing with the aging of the population. OFF episodes are
the re-emergence or worsening of symptoms (motor and non-motor)
otherwise controlled by medications. OFF episodes can happen at any
point during the day, often occurring in the morning after awakening and
periodically throughout the day. OFF episodes can be characterized, in
part, by tremor, stiffness or slow movement. These episodes may disrupt
a person’s ability to perform everyday activities and may be burdensome
for patients, family and caregivers. OFF episodes can be experienced by
40 to 60 percent of people with PD 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 www.ds-pharma.com.
SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.
© 2018 Sunovion Pharmaceuticals
Inc. All rights reserved.
For a copy of this release, visit Sunovion’s website at www.sunovion.com
References
1 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 March 2018.
2 “Efficacy, Safety and
Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes
in Patients with Parkinson's Disease. Available online: https://clinicaltrials.gov/ct2/show/NCT02469090.
Accessed December 2017.