UC physician presents research at annual neurology meeting
Data promising for extended-release Parkinson’s drug
The University of Cincinnati’s Alberto Espay, MD, will present Parkinson’s disease research at the American Academy of Neurology’s annual meeting, April 22-27, in Boston, Massachusetts, and online.
Extended-release drug effective at lengthening ‘on time’
Parkinson’s symptoms such as tremors, slowness and stiffness are caused by low levels of dopamine in the body. For decades, doctors have treated Parkinson’s by giving patients levodopa, the precursor in our body that makes dopamine.
“Levodopa is a replacement strategy. We all make levodopa, but Parkinson's patients make less of it,” said Espay, the James J. and Joan A. Gardner Family Center for Parkinson’s Disease Research Endowed Chair in UC’s Department of Neurology and Rehabilitation Medicine and a UC Health physician.
Espay said levodopa is very effective and typically brings people nearly back to normal motor function, but its benefits tend to wear off sooner after a few years, requiring multiple dosing.
To counteract this, clinicians led by Espay tested a new formulation of levodopa called IPX203. The drug, taken orally, is designed with both immediate release and long-term release capsules of levodopa.
In a nine-month, multicenter safety extension trial, the researchers found three daily doses of IPX203 was safe and extended the duration of patients’ “on time,” or the time when the medication is working and symptoms are lessened, compared to five daily doses of standard levodopa.
While this specific study examined the effectiveness of a low dose frequency of IPX203, Espay said he envisions patients may still take additional doses a day to increase their “on time” even further. Analysis of the trial data showed about 1.55 hours of extra “on time” with IPX203 compared to standard levodopa.
“Once this treatment becomes available, we imagine that rather than us cutting the number of doses from five to three, we might keep the number of doses the same to obtain a far more robust increase in ‘on time,’” Espay said. “Fewer doses are better for patients, but if it’s the choice between fewer doses or no ‘off time,’ they say let’s get to no ‘off time’ however many doses it takes.”
With trial data submitted to the Food and Drug Administration, Espay said he anticipates IPX203 could be FDA approved by the fall or early winter. IPX203 would be the second extended-release levodopa pill approved, with several formulations of the drug through infusion pump currently being tested as well.
“The current options are still not quite where we would want them to be,” Espay said. “Any kind of improvements upon the delivery of levodopa are very much welcome.”
Espay will present “Long-term Safety and Efficacy of IPX203 in Parkinson’s Disease Patients with Motor Fluctuations: A 9-Month Open-label Extension Trial” at 4:30 p.m. April 25 during the Movement Disorders: Trials session, presented in person and online.
Gathering more info to personalize patient treatments
When Parkinson's patients’ motor fluctuations become more difficult to manage, they are considered candidates for more advanced therapies. But what advanced therapy will be best for each specific patient?
This is the question Espay and colleagues hope to shed light on through the PROSPECT study.
“We’re trying to follow patients across several sites that are at this stage to understand what makes people candidates for different advanced therapies,” he said. “What are the features that might make them good versus poor candidates? What would be the best strategy for different people? It's a naturalistic approach to getting a sense of where the best interventions are for what kind of people.”
Currently, advanced therapies are used when current treatments aren’t meeting a patient’s needs, but Espay said there is little data that predicts whether a therapy will be successful for each individual patient.
“We’re trying to more carefully calibrate the decision based on a variety of different factors, some of which aren’t immediately considered as part of the equation,” he said. “We’re trying to determine how people do at the other side of the fence after the treatment is completed.”
Long term, Espay said he hopes the data collected through the study will help create an algorithm that helps predict whether a therapy would be useful for a patient, or if the best option would be to not start any advanced therapies at all due to risks being greater than benefits.
“This would give us the resources to create data-driven information to guide people being considered for different advanced therapies. We’re not yet where we need to be in terms of that decision,” he said.
Espay will present “Evaluation of the Clinical Outcomes and Disease Burden in Advanced Parkinson’s Disease Patients: PROSPECT Study Preliminary Results” from 8-9 a.m. April 26 during a poster session.
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Featured photo at top of 3-D illustration of a dopamine molecule. Photo/Dr_Microbe/iStock.