Sunovion has resubmitted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to the Food and Drug Administration (FDA) for the treatment of motor fluctuations, or OFF episodes, experienced by 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.
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.
“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 disease,” said Antony Loebel, MD, President and CEO of Sunovion.
For more information visit sunovion.com.