Sunovion Pharmaceuticals announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD) in response to the January 29, 2019 Complete Response Letter (CRL). This submission included information about intended packaging as well as additional analyses of clinical data.
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. 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 on-demand treatment options available for motor OFF episodes.
“OFF episodes in people with Parkinson’s disease can occur at any point throughout the day, often occurring in the morning after awakening and periodically throughout the day and can disrupt the ability to perform everyday activities,” said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. “We look forward to continuing our dialogue with the FDA during the review period with the intention of bringing a much needed on-demand treatment option for OFF episodes to those living with Parkinson’s disease.”
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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. Apomorphine sublingual film has not been approved by the U.S. Food and Drug Administration (FDA). In October 2016, Sunovion acquired Cynapsus Therapeutics, along with its product candidate APL-130277.
By 2020 nearly one 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 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.