Kynmobi (apomorphine hydrochloride) is a sublingual (under the tongue) formulation of apomorphine developed by Sunovion to reduce off episodes in Parkinson’s disease. Off episodes occur when symptoms reappear as a therapy wears off, before the next dose takes effect.
The U.S. Food and Drug Administration (FDA) approved Kynmobi in May 2020. A similar medication, called Apokyn, is also approved to treat off episodes in these patients. However, Apokyn is an injection treatment with side effects can cause pain, nausea, and injection-site reactions.
How does Kynmobi work?
Parkinson’s is characterized by a loss of nerve cells in the brain. This causes a decrease in dopamine, an important signaling molecule. Many treatments for Parkinson’s disease aim to increase dopamine levels in the brain either by reducing dopamine clearance or increasing dopamine secretion.
However, in between medication doses, patients — especially those with more advanced disease — often experience so-called off periods. This is when their dopamine levels dip low, leading to a worsening of symptoms.
Kynmobi is a fast-acting, thin-strip film coated with apomorphine. Apomorphine is a small molecule that binds to the dopamine receptors and activates them, mimicking the effect of dopamine in the brain.
Kynmobi in clinical trials
Sunovion sponsored a Phase 2 clinical trial (NCT02228590) to assess Kynmobi‘s safety, effectiveness, and tolerability. A key finding from this trial was that the 19 patients given the treatment were able to go from off to on states without the complications of injecting apomorphine.
A Phase 3 clinical trial (NCT02469090) recruited 219 Parkinson’s patients who were taking levodopa and experiencing at least one off episode that lasted at least two hours a day. During the trial, patients were given either Kynmobi or a placebo for 12 weeks, and could take the medication up to five times each day. To analyze the effects of the treatment, researchers used the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part 3 score, looking at the pre-dose period to 30 minutes after dosing at week 12.
Initial topline results from 109 patients indicated a significant improvement in MDS-UPDRS scores in those using Kynmobi compared to those who received the placebo.
Patients also tolerated the treatment well. The most common side effects were nausea, sleepiness, and dizziness.
Ongoing clinical trials
A second Phase 3 clinical trial (NCT02542696) is underway in 226 Parkinson’s patients at sites across the U.S., Canada, and Europe. The aim of this open-label study, due to end in March 2023, is to determine the long-term safety and effectiveness of Kynmobi.
Some patients in these Phase 3 trials are also taking part in a sub-study. It aims to determine whether computer technology can quickly measure disease progression and speed the development of new treatments. Participants use a wearable device and smartphone application to help researchers collect information about the effects of Kynmobi, including its ability to improve movement. The Michael J. Fox Foundation and Intel Corporation developed the application.
Kynmobi was approved by the FDA as a sublingual film at 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg doses, to be taken as needed up to a maximum of five times a day. Each use of the treatment should be at least two hours apart, with more than 30 mg taken at any one time.
Last update: May 26, 2020
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