FDA Accepts New Drug Application for Sublingual Apomorphine to Treat Motor Fluctuations

The Food and Drug Administration (FDA) has accepted a new drug application (NDA) for apomorphine sublingual film (APL-130277; Sunovion, Marlborough, MA) to treat motor fluctuations (OFF episodes) experienced by people with Parkinson disease (PD). 
 

Results of a phase 3 study (NCT03391882) of the therapy were published in Lancet Neurology that showed the treatment to be an efficacious on-demand treatment for off episodes of PD. patients with Parkinson's disease.  Within 30 minutes of administering sublingual apomorphine vs placebo, indviduals had a 11.1 (95% CI, 8.2-14.0) vs 3·5 (95% CI, 0.9-6.1) improvement in the Movement Disorders Socity Unified Parkinson Disease Rating Scale (MDS-UPDRS) score. Adverse events, primarily oropharyngeal intolerance, were high, however, and approximately one-thid of participants discontinued participation.

“The unpredictable nature of OFF episodes can be extremely challenging and disruptive to the daily lives of people living with PD as well as their care partners,” said Antony Loebel, MD, president and chief executive officer, Sunovion. “We look forward to working with the FDA over the remaining review period.”
OFF episodes can cause severe disruption for someone living with PD and may worsen in frequency and severity over the course of the illness. 
 

Apomorphine sublingual film, a novel formulation of the dopamine agonist apomorphine, is being developed as a fast-acting on-demand treatment for all types of motor OFF episodes, including morning OFF, unpredictable OFF, delayed ON/partial ON, and end-of-dose wearing OFF. 
 

The therapy is designed as a potential option that may be used to treat OFF episodes up to 5 times throughout the day, helping people rapidly convert from the OFF to the ON state.