Following a review of the New Drug Application (NDA), the Food and Drug Administration (FDA) has requested additional information and analyses for apomorphine sublingual film (APL-130277; Sunovion), an investigational treatment for OFF episodes in patients with Parkinson disease (PD).
Apomorphine sublingual film is being developed for the on-demand management of all types of motor OFF episodes (morning OFF, unpredictable OFF, and end-of-dose wearing OFF). It is a new formulation of the dopamine agonist apomorphine, intended for rapid conversion from the OFF to the ON state. Currently, only a subcutaneous (SC) formulation of apomorphine is available for the acute, intermittent treatment of hypomobility, OFF episodes in advanced PD.
In the Complete Response Letter (CRL), the FDA noted that it was unable to approve the application in its present form, however the Agency did not request additional clinical studies.
Commenting on the CRL, Antony Loebel, MD, Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group said, “Sunovion remains committed to working with the FDA to address its requests so that we can bring apomorphine sublingual film to patients as expeditiously as possible.”
For more information visit Sunovion.us.