Sunovion Announces FDA Filing Acceptance of Resubmitted NDA for Apomorphine Sublingual Film

Sunovion Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has accepted its 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), which was resubmitted on November 21, 2019. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 21, 2020.

"The unpredictable nature of OFF episodes can be extremely challenging and disruptive to the daily lives of people living with Parkinson’s disease as well as their care partners," said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. "We look forward to working with the FDA over the remaining review period."

"People with Parkinson's have shared that OFF episodes can be disruptive and hamper their quality of life. New treatments could mean greater symptom control for more people, improving their ability and confidence to navigate daily life with the disease," said Todd Sherer, PhD, CEO of The Michael J. Fox Foundation for Parkinson’s Research.

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, delayed ON/partial ON and end-of-dose wearing OFF. 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. OFF episodes may worsen in frequency and severity over the course of the illness. While OFF episodes are experienced by 40 to 60 percent of people with PD, there are limited treatment options available to treat OFF episodes when they occur.

Apomorphine sublingual film (APL-130277), a novel formulation of apomorphine, a dopamine agonist, is being developed as a fast-acting on-demand treatment of OFF episodes associated with Parkinson’s disease (PD). Apomorphine sublingual film is designed to offer a potential option that may be used to treat OFF episodes associated with PD up to five times throughout the day. It may help people with PD rapidly convert from the OFF to the ON state. Results of the pivotal Phase 3 study (CTH-300) of apomorphine sublingual film were recently published in Lancet Neurology. 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. Two early-stage APL-130277 trials were funded in part by The Michael J. Fox Foundation.

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). 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 worsening or re-emergence of PD symptoms (motor and non-motor) otherwise controlled by medications. These episodes may disrupt a person’s ability to perform everyday activities and may be burdensome for patients, family and care partners. 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.

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