Apomorphine Sublingual Film Successful in Parkinson Disease

February 26, 2020

The executive director of clinical research at Sunovion spoke about the key takeaways from a phase 3 trial of self-administered apomorphine sublingual film in Parkinson disease.

Recent data from a post-hoc analysis of a phase 3 trial of Sunovion Pharmaceuticals’ apomorphine sublingual film suggests that among patients with Parkinson disease, self-administration of the drug at home is more often associated with a full ON response at 30 minutes post-dose compared with placebo.1

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.

To find out more about these data, presented at the recent Pan American Parkinson’s Disease & Movement Disorders Congress, NeurologyLive spoke with Bradford Navia, MD, PhD, executive director, clinical research, Sunovion.

NeurologyLive: What are the key takeaways from these data for the clinical community?

Bradford Navia, MD, PhD: This is a new post-hoc analysis of patient-reported data from the pivotal trial of apomorphine sublingual film, and the first to be presented at a medical meeting. Previous pivotal clinical data shared has demonstrated the efficacy of apomorphine sublingual film for the treatment of OFF episodes in a physician’s office setting only.

The data presented at MDS-PAS looked at the efficacy of self-administered apomorphine sublingual film vs placebo for the treatment of “OFF” episodes in patients with Parkinson’s disease (PD) based on patient-reported home dosing and response diaries.

Key takeaways for the clinical community include:

  • Across all diary entries, 77 percent of patients self-reported a full ON* response at 30 minutes post-dose with apomorphine sublingual film compared to 26 percent with placebo.
  • Patients self-reported a full ON response at a similar rate across all periods of the day and across all doses. An instance of full ON response at 30 minutes post-dose across all diary days by time were higher for patients who received apomorphine sublingual film than placebo. Full ON response is defined as providing benefit with regard to mobility, stiffness, and slowness, whereby normal daily activities could be performed and were comparable to or better than normal response to PD medications prior to study enrollment.

In patients with PD, motor status is usually assessed using a standardized examination (e.g., Movement Disorder Society Unified Parkinson’s Disease Rating Scale Part III); however, home dosing and response diaries serve as an important tool to monitor patient motor function over time in the home environment. These results suggest patients are able to self-administer apomorphine sublingual film.

Are there any advantages to this formulation of apomorphine over available therapies?

We cannot draw comparisons between apomorphine sublingual film and other treatments for OFF episodes and/or PD.

Sunovion believes that the sublingual administration is well suited to the apomorphine profile and the needs of people living with PD. This novel administration of apomorphine provides patients and physicians another method of administering this proven Parkinson’s disease medicine.

The objective in pursuing an under-the-tongue formulation was to develop a method of providing apomorphine that will be quickly absorbed into the bloodstream and delivered to the brain. This formulation is associated with a unique pharmacokinetic profile that may improve safety and tolerability. The sublingual delivery is designed to allow the apomorphine to bypass the GI tract, where there are factors that may slow or prevent the medication from reaching the brain.

Apomorphine sublingual film was shown to be effective and generally safe and well-tolerated in a pivotal multicenter U.S. trial. These results were recently published in Lancet Neurology.2 If approved, apomorphine sublingual film would be the first and only on-demand treatment of OFF episodes that is administered sublingually.

Transcript edited for clarity.

REFERENCES

1. 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, FL.

2. Olanow CW, Factor SA, Espay AJ, et al. Apomorphine sublingual film for off episodes in Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 study. 2019;19(2): 135—144. doi: 10.1016/S1474-4422(19)30396-5.