Health Canada Approves Kynmobi Sublingual Film to Treat Off Episodes
Kynmobi (apomorphine hydrochloride) soluble film has been approved by Health Canada as an on-demand treatment for off episodes in people with Parkinson’s disease, its developer Sunovion, announced.
Sunovion now is working to make Kynmobi available in pharmacies across Canada as soon as possible.
“Health Canada approval is an important step forward for people living with Parkinson’s disease, as they now have more options that can help manage the effects of OFF episodes as they occur,” Karen Lee, PhD, CEO of Parkinson Canada, said in a press release.
Kynmobi (previously known as APL-130277) is an apomorphine film that is placed under-the-tongue (sublingual therapy) when patients start experiencing an off episode — periods when symptoms reappear as a therapy wears off. The treatment, which was approved for the same indication by the U.S. Food and Drug Administration in May, may be used up to five times a day.
Once in the bloodstream, apomorphine can cross the blood-brain barrier — a semipermeable membrane that protects the brain from the external environment — and mimic the effects of dopamine in the brain. This counteracts the loss of dopamine-producing neurons in the brain, a hallmark of Parkinson’s disease.
Kynmobi’s effectiveness, safety and tolerability was evaluated in a Phase 3 clinical trial (NCT02469090) that compared the oral medication to placebo as an on-demand treatment for off periods.
The trial included patients who had at least two hours of total off periods per day, including predictable morning off episodes, despite being responsive to levodopa treatment. In an initial open-label phase, all participants were given increasing doses of Kynmobi (10−35 mg) until an optimal dose was found.
Patients were then assigned randomly to either Kynmobi or placebo, and could take the medication up to five times a day for 12 weeks.
The trial’s main goal was improvements in motor symptoms — defined as changes on the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III — from before dosing to 30 minutes after dosing at week 12.
Data showed that patients who received Kynmobi experienced a mean reduction of 7.6 points in their MDS-UPDRS scores compared to those taking placebo at week 12 of the trial.
The first clinical improvements were seen as early as 15 minutes after dosing, and persisted for up to 90 minutes.
More patients given Kynmobi achieved full control of their motor symptoms (31%) — a full “on” response — within 30 minutes at week 12, compared with 14% of those given a placebo.
“The Health Canada approval of KYNMOBI provides healthcare providers and people living with Parkinson’s disease with a novel treatment option that allows a quick and reliable transition from OFF to ON so they can more easily function in their daily lives,” said Antony Loebel, MD, president and CEO at Sunovion.
Kynmobi was generally well-tolerated, with most treatment-related side effects being mild to moderate. The most common side effects were nausea, sleepiness, and dizziness. One person with known cardiac risk factors who was treated with Kynmobi died due to heart failure.
“The unpredictable and frequent nature of OFF episodes, which can occur despite people taking their oral maintenance medications as prescribed, makes this a particularly challenging and burdensome facet of Parkinson’s disease,” said Anthony E. Lang, MD, professor at the University of Toronto and Jack Clark Chair for Parkinson’s Disease Research, and director of the Edmond J. Safra Program in Parkinson’s disease at Toronto Western Hospital.
Kynmobi “is a welcome on-demand treatment that physicians can offer patients to help rapidly improve their PD OFF episodes,” he said.
