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In two clinical studies, Kynmobi (apomorphine hydrochloride) was associated with greater and faster motor improvement than was levodopa among Parkinson’s patients experiencing off episodes, when disease symptoms recur.
The results of the two trials support Kynmobi’s use by patients who have delayed responses to levodopa, researchers said.
The findings were presented as a poster, titled “Motor Responses to Apomorphine Sublingual Film Compared With Levodopa in Patients With Parkinson’s Disease and “OFF” Episodes,” at the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting. That meeting is being held online April 17–22.
Kynmobi is a sublingual or under-the-tongue formulation of apomorphine that is designed to reduce off episodes — times when symptoms reappear as a therapy wears off — in Parkinson’s disease. It can be taken up to five times a day, at doses ranging from 10 mg to 30 mg.
Here, researchers evaluated the therapy in two trials involving Parkinson’s patients who experienced off episodes while taking stable medications for their condition. The trials were a pivotal Phase 3 North American study (NCT02469090), and a long-term, open-label safety and efficacy study (NCT02542696). The Phase 3 open-label study is still recruiting participants at several of its 73 locations, with further information available here.
A total of 384 adults, ages 18 and older, with a mean age of 63.8, participated in the two studies. Of them, 109 were involved in the pivotal study and 275 in the long-term study.
Kynmobi doses for each participant were adjusted during sequential office visits, while those individuals were experiencing off episodes. During these periods, patients took their prescribed morning carbidopa/levodopa medications without other add-on therapies. The doses ranged from 10–35 mg, and were titrated in increasing 5 mg increments, while patients were assessed for full-on responses.
Investigators compared response times, or how long it took a medication to “kick in,” as well as changes in motor symptoms among participants after taking Kynmobi or levodopa. Motor responses were assessed using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score. Measurements were made before taking a dose and at 15, 30, and 60 minutes (one hour) after dosing.
While pre-dose Part III scores were comparable between the two groups (41.9 for the Kynmobi group vs 42.2 for the levodopa group), motor improvement — as measured by drops in the assessment scores — occurred faster among people taking Kynmobi.
At 15 minutes, scores in the Kynmobi group fell by 13.9 points, while those in the levodopa group decreased by 6.7 points. The responses to Kynmobi remained stronger at 30 minutes (minus 22.9 points vs. minus 16.3 points), until 60 minutes, when a levodopa peak response occurred. At the one-hour mark, the results were minus 24.3 points in the Kynmovi group versus minus 24.4 points in the levodopa group.
Additionally, more individuals were classified as responders to Kynmobi — meaning a reduction in Part III scores by at least 30% versus pre-dosing — than to levodopa.
At 15 minutes, the Kynmobi group saw a 52% response rate, compared with 21% among levodopa users. By 30 minutes, those response rates were 88% for Kynmobi versus 65% for levodopa. The rates leveled off at 60 minutes, with levodopa responses rising to 92%, while those for Kynmobi held steady at 88%.
“Consistent with previous findings,” the researchers concluded, “[Kynmobi] was associated with greater motor improvement and more responders at earlier time points versus levodopa, further supporting its use in patients with a delayed ‘on’ response to levodopa.”
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