New Sublingual Film for Treatment of Parkinson Disease Granted FDA Approval

Officials with the FDA have approved apomorphine hydrochloride (Kynmobi, Sunovion Pharmaceuticals) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in patients with Parkinson disease (PD).

The therapy is a novel formulation of apomorphine, a dopamine agonist. It is the first sublingual therapy for the fast-acting, on-demand treatment of OFF episodes associated with Parkinson disease, according to Sunovion, and may be used up to 5 times a day.

OFF episodes are re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. These episodes may be characterized, in part, by tremor, stiffness, slowed movement or other symptoms, and can occur in the morning upon waking and throughout the day.

“Several years after a person is diagnosed with Parkinson disease they may notice problems such as having trouble getting out of bed in the morning or having difficulty getting out of a chair, or that they feel frozen while trying to walk as the effect of their maintenance medication diminishes,” said Stewart Factor, DO, professor of neurology, director of the Movement Disorders Program and vance lanier chair of neurology at Emory University School of Medicine in a prepared statement.

According to Todd Sherer, PhD, CEO, The Michael J. Fox Foundation for Parkinson’s Research, research and discussions with the Parkinson community have found that OFF episodes can significantly disrupt a patient’s daily life.

“The Foundation supported early clinical development of sublingual apomorphine, and this approval brings an important new treatment option for people with PD who experience OFF,” said Sherer, in a prepared statement.

Phase 3 clinical trial results, published in Lancet Neurology, demonstrated that patients with PD receiving apomorphine hydrochloride sublingual film experienced significant improvements in motor symptoms at 30 minutes after dosing at week 12, with a mean reduction of 7.6 points, compared to placebo, on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. Initial clinical improvements were seen at 15 minutes post-administration. Additionally, a significantly higher percentage of people treated with apomorphine hydrochloride sublingual film had a patient-rated full ON response within 30 minutes at week 12, compared with people receiving placebo.

The therapy was generally well-tolerated in the clinical trial. Among the most frequently reported treatment-emergent adverse events in this study (occurring in more than 5% of patients and at a rate greater than placebo) were nausea, oropharyngeal reactions, somnolence and dizziness.

Apomorphine hydrochloride sublingual film is expected to be available in United States pharmacies in September 2020, according to Sunovion.

REFERENCE

Sunovion Announces U.S. FDA Approval of KYNMOBI™ (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes [news release]. Marlborough, MA; May 21, 2020: Sonovion Pharmaceuticals. businesswire.com/news/home/20200521005786/en/Sunovion-Announces-U.S.-FDA-Approval-KYNMOBI%E2%84%A2-apomorphine. Accessed May 21, 2020.