The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for apomorphine sublingual film (APL-130277; Sunovion) for the treatment of OFF episodes in patients with Parkinson disease (PD).

The sublingual film is a novel formulation of apomorphine, a dopamine agonist. It is designed for use as a fast-acting on-demand treatment for all types of motor OFF episodes (morning OFF, unpredictable OFF, and end-of-dose wearing OFF) up to 5 times a day. Currently, only a subcutaneous (SC) formulation of apomorphine is available for the acute, intermittent treatment of hypomobility, OFF episodes in advanced PD. 

Results from a double-blind, placebo-controlled trial investigating the safety and efficacy of the sublingual film showed that the on-demand treatment was effective for most PD patients. As for safety, oropharyngeal events were the most common adverse effects reported and led to almost a third of patients discontinuing treatment. 

Earlier this year, the FDA issued a Complete Response Letter to Sunovion rejecting the initial NDA submission of apomorphine sublingual film. The latest NDA submission includes additional analyses of clinical data and more information on the intended packaging.

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“The unpredictable nature of OFF episodes can be extremely challenging and disruptive to the daily lives of people living with Parkinson disease as well as their care partners,” said Antony Loebel, MD, President and CEO at Sunovion. “We look forward to working with the FDA over the remaining review period.”

A Prescription Drug User Fee Act (PDUFA) date of May 21, 2020 has been set for the application.

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