Self-administration of the drug led to statistically significant motor status changes within 30 minutes of treatment.
Antony Loebel, MD
Findings from a post-hoc analysis of a phase 3 trial assessing the safety and efficacy of apomorphine sublingual film (Sunovion Pharmaceuticals) showed that among patients with Parkinson disease (PD) who self-administered the drug at home, treatment with apomorphine was more often associated with a full ON response at 30 minutes post-dose compared with placebo. Results of the study were presented at the recent Pan American Parkinson’s Disease & Movement Disorders Congress.
In December 2019, Sunovion Pharmaceuticals announced that the FDA had accepted its NDA
for the drug based on data from the phase 3 CTH-300 trial (NCT02469090), which included patients who were at least 18 years of age, had clinically meaningful response to levodopa with well-defined early morning OFF episodes, and had an Mini-Mental State Exam score >25. Those excluded from the study had atypical or secondary parkinsonism, were previously treated with a neurosurgical procedure for PD, and participated in a clinical trial within 30 days prior to initial screening visit. Results of that study demonstrated a -11.1 mean change in the Unified Parkinson’s Disease Rating Scale (UPDRS) part 3 at 30 minutes post-treatment at week 12 compared to -3.5 with placebo.
In this analysis, 109 patients were randomized 1:1 to either apomorphine sublingual film (10 mg-35 mg; n = 54) or placebo (n = 55) for 12 weeks. Prior to in-office visits at weeks 4, 8, and 12, patients completed at-home dosing and recorded their dose timing and response in a diary, indicated whether they achieved full ON or OFF 30 minutes after treatment.
Overall, patients administered a mean of 2.2 and 2.5 daily doses of apomorphine sublingual film and placebo, respectively. Among those who received apomorphine, 79% reported a full ON response at 30 minutes post-dose within the 2 days prior to their in-office visit compared to 31% of patients taking placebo (P
<.0001). When assessing all diary entries, 77% of patients using apomorphine sublingual film reported achieving a full ON response at 30 minutes post-dose compared with 26% of the placebo group. Notably, a similar response rate was recorded throughout the day, with 71% reported full ON between 5AM and 9AM and 86% reported full ON between 10PM and 5AM.
“The unpredictable nature of off episodes can be extremely challenging and disruptive to the daily lives of people living with Parkinson’s disease as well as their care partners,” Antony Loebel, MD, president and chief executive officer, Sunovion, said in a statement in December 2019. “We look forward to working with the FDA over the remaining review period.”
In December, the FDA announced the Prescription Drug User Fee Act (PDUFA) action date for the product is on or before May 21, 2020. If approved, apomorphine sublingual film would be the first on-demand OFF episode treatment administered sublingually.
Hauser R, Mehta S, Maulis M, et al. Patient-reported motor responses to apomorphine sublingual film based on home dosing and response diaries. Presented at: 2020 Pan American Parkinson’s Disease & Movement Disorders Congress. February 14-16, 2020; Miami, F