Kynmobi Sublingual Film for ‘Off’ Episodes Now Available in US
Kynmobi (apomorphine hydrochloride), a sublingual film to treat “off” episodes in people with Parkinson’s disease, is now available in the United States by prescription, its developer Sunovion announced.
“People living with Parkinson’s disease can potentially spend hours each day navigating disruptions caused by off episodes, which may result in reduced motor function and present challenges performing daily activities,” said Thomas Gibbs, Sunovion’s chief commercial officer, in a press release.
The medication dissolves under the tongue and can be used when symptoms first begin to worsen. It can be taken up to five times a day, at doses ranging from 10 mg to 30 mg.
The U.S. Food and Drug Administration approved Kynmobi in May, following the results of a Phase 3 study (NCT02469090) comparing the therapy to placebo among 141 patients who responded to levodopa treatment, but had at least two hours of “off” periods per day.
Of those, 109 patients achieved full “on” status in response to the film. The remaining 32 participants left the study for a variety of reasons, including adverse events (side effects) and failure to respond to the medication at any dose.
The patients who continued the study tended to be younger (62.7 years vs. 66.2, on average), had a longer average time diagnosed (9.0 vs. 7.8 years), and used lower doses of levodopa at the trial’s start (1,033 mg vs. 1,316 mg).
Patients received different doses of Kynmobi (10, 15, 20, 25, 30, and 35 mg), based on which one worked best for them.
The trial’s main goal was lessening of motor symptoms from before dosing to 30 minutes after dosing at week 12, as measured using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III.
On average, these scores improved over the study period, falling by 23.7 points. This change was consistent across all dose groups and 71.6% of patients taking Kynmobi reported a full “on” status — or achieving full control of their motor symptoms — within 30 minutes.
Kynmobi continued to show clinically meaningful improvement in MDS-UPDRS Part III scores at 90 minutes after dosing.
Patients taking the lowest dose of Kynmobi (10 mg) had the highest response rate, at 95%. Response rate generally declined as dosage increased, to a low of 44.4% among those taking 30 mg. Patients who received 10 mg also began the trial with lower average MDS-UPDRS Part III scores.
Patients tolerated Kynmobi well throughout the trial, with 58.2% reporting some side effects. The most common were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and sleepiness (11.3%). Only one patient reported a serious side effect — a staphylococcal infection — which was deemed unrelated to the medication.
Patients taking the 10 mg dose reported the fewest side effects (27.8%) and those taking 35 mg reported the most (75.0%).
The medication maintained its efficacy and safety profile for nearly a year of use, according to interim data presented at the International Parkinson and Movement Disorder Society Virtual Congress 2020.
Sunovion stated in an email, that additional Kynmobi data would be published in the October issue of Parkinsonism and Related Disorders.
“Reduced mobility associated with off episodes can be one of the most troubling and burdensome aspects for people living with Parkinson’s disease,” said Stuart Isaacson, MD, director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida. “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,” he said.
More information, including patient assistance and reimbursement support, is available here and through Sunovion Answers, or by calling 1–844–596–6624 (844–KYNMOBI), Monday through Friday, 8 a.m. to 8 p.m. ET.