MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD). The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is January 29, 2019.
“Through our ongoing work with people living with Parkinson’s disease, we know the community is eager for more treatment options that may help alleviate OFF episodes, which are often disruptive to their daily lives,” said Todd Sherer, Ph.D., CEO of The Michael J. Fox Foundation for Parkinson’s Research. “We’re heartened to see apomorphine sublingual film is successfully continuing through the regulatory process, and we are hopeful for its approval and future availability.” Two early-stage APL-130277 trials were funded in part by The Michael J. Fox Foundation.
Apomorphine sublingual film is being developed as a fast-acting medicine for the on-demand treatment of all types of motor OFF episodes, including morning OFF, unpredictable OFF and end-of-dose wearing OFF. Motor 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
“We are encouraged that the FDA has accepted our NDA for apomorphine sublingual film,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “There are currently few treatment options available to Parkinson’s disease patients for the as needed treatment of OFF episodes. We look forward to working with the FDA during the review period so that we can bring a much needed new treatment option to people living with Parkinson’s disease and OFF episodes.”
About Apomorphine Sublingual Film (APL-130277)
Apomorphine
sublingual film (APL-130277), a novel formulation of apomorphine, a
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 the U.S. is currently approved as a subcutaneous
injection. Apomorphine sublingual film is intended to rapidly convert
people living with PD from the OFF to the ON state and has been studied
for treatment of motor OFF episodes up to five times per day.
Apomorphine sublingual film has not been approved by the U.S. Food and
Drug Administration (FDA). 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 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
More than one
million people in the U.S. and 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 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 are
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
are experienced by 40 to 60 percent of people with PD and may worsen in
frequency and severity over the course of the illness.1
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.
