Sunovion Launches Sublingual Therapy for “Off” Episodes in Parkinson Disease

Sunovion announced the availability of its apomorphine hydrochloride (Kynmobi) sublingual film for the acute intermittent treatment of “off” episodes in patients with Parkinson disease (PD), according to a press release.

Apomorphine HCl was approved by the FDA on May 21, 2020 and its commercial activities were initiated on September 29, 2020. Apomorphine HCl is a novel formulation of apomorphine, a non-ergoline dopamine agonist, and the first and only sublingual therapy for this indication. The film dissolves under the tongue for on-demand treatment of off episodes in patients with PD as they occur. 

A phase 3 clinical study evaluated apomorphine HCl in patients with PD. According to the results, patients treated with apomorphine HCl experienced significant improvements in motor symptoms at 30 minutes after dosing at week 12, compared with placebo, with numerical improvement seen at 15 minutes post-administration. Additionally, a significantly higher percentage of patients treated with apomorphine HCl had a patient-rated full “on” response within 30 minutes at week 12, compared with those receiving placebo. The phase 3 clinical study results were published in Lancet Neurology.

Apomorphine HCl was generally well-tolerated, with the most frequently reported treatment-emergent adverse effects in the study being nausea, oropharyngeal reactions, somnolence, and dizziness.

Interim data from an open-label phase 3 extension study recently presented at the International Parkinson and Movement Disorder Society Virtual Congress 2020 also support apomorphine HCl’s long-term efficacy, safety, and tolerability in up to 48 weeks of patient use.

“Reduced mobility associated with OFF episodes can be one of the most troubling and burdensome aspects for people living with Parkinson’s disease,” Stuart Isaacson, MD, director of Parkinson’s Disease and Movement Disorders Center of Boca Raton, said in a statement. “This is intensified as Parkinson’s disease progresses and OFF episodes become more frequent. The availability of Kynmobi provides a new, effective on-demand treatment option that we can offer patients to use as needed for OFF episodes when they occur.”

Apomorphine HCl is now available in the United States.

Reference

1. Sunovion Announces the Commercial Launch of Kynmobi (Apomorphine Hydrochloride) Sublingual Film For the Treatment of Parkinson’s Disease Off Episodes. News release. Sunovion; October 5, 2020. Accessed October 7, 2020. https://news.sunovion.com/press-releases/press-releases-details/2020/Sunovion-Announces-the-Commercial-Launch-of-KYNMOBI-apomorphine-hydrochloride-Sublingual-Film-for-the-Treatment-of-Parkinsons-Disease-OFF-Episodes/default.aspx​