Teeth-retainer system can supply steady high doses of levodopa
DopaFuse led to better control of motor symptoms in small study
A small pump that’s worn as part of a teeth retainer can continuously release high daily doses of a paste formulation containing levodopa and carbidopa, easing motor symptoms for patients who need a steady supply of medication, such as those with advanced Parkinson’s disease, a study has found.
The study, “Non-invasive, continuous oral delivery of solid levodopa-carbidopa for management of Parkinson’s disease,” was published in Scientific Reports by researchers at SynAgile, which developed DopaFuse, a similar system that’s been under Phase 2 clinical testing for Parkinson’s.
Motor symptoms of Parkinson’s occur due to a shortage of dopamine, a signaling molecule in the brain that’s involved in the control of voluntary movements. Levodopa, a mainstay treatment for Parkinson’s, provides the brain with material to produce dopamine.
While oral levodopa — often given in combination with carbidopa to help more of it reach the brain — can help keep motor symptoms under control, many patients experience off periods, where symptoms reappear between doses due to fluctuating levels of medication in the body.
Medications with short half-lives, or the time it takes for the amount of a medication to reduce by half, act quickly and are removed from the body just about as fast, meaning they work only for a short time. Because of this, patients often need to take them frequently or even continuously to keep the effects of the medications steady.
DopaFuse led to more stable levels of levodopa in patients
To address this, SynAgile developed DopaFuse, a small pump attached to a retainer worn on the teeth that releases continuous amounts of levodopa into the mouth. In a Phase 2 study (NCT04778176), DopaFuse led to more stable levels of medication in the blood and better control of motor symptoms in Parkinson’s patients.
Until now, delivering daily doses over 100 mg without invasive methods was considered nearly impossible. This new system changes that by allowing doses as high as 1,200 mg per day to be delivered, the researchers noted.
After meals, “typically after breakfast, lunch, and dinner,” the patient places a prefilled, disposable extruder containing 1 mL of medication into a built-in pocket. This extruder pushes out a semisolid paste, containing 63% of levodopa and carbidopa, onto the tongue side of the teeth. The paste mixes with saliva and is swallowed.
“Considering the broad design space enabled by tuning the formulation, extruder design, and dosing strategy, patients suffering of other conditions might also benefit of the continuous oral administration of short-lived drugs,” the researchers wrote.
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