New drug for Parkinson’s shown to be effective in clinical trials: 'Very encouraged'

A new drug has shown promise in combating Parkinson’s disease while minimizing unwanted side effects.

The once-daily pill, tavapadon, was found to relieve symptoms — including stiffness, coordination, tremors and movement — for a longer period of time for patients who were also taking at least 400 mg of levodopa a day and were experiencing "motor fluctuations," which are periods of time when the medication wears off and symptoms return, according to the study.

Until now, levodopa has been the standard first-line treatment for Parkinson’s patients. 

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Levodopa — which is converted into dopamine in the brain and targets the D2/D3/D4 dopamine receptors — has been linked to side effects including sleep disorders, hallucinations, impulse control behavioral disorders, weight gain, leg swelling and blood pressure changes, according to the researchers.

In the study, tavapadon — which works by mimicking dopamine and targeting the D1/D5 receptors — was found to have the same benefits as levodopa without the adverse effects, according to Hubert H. Fernandez, MD, lead study author and director of the Center for Neurological Restoration at Cleveland Clinic.

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"It provides patients with another option to alleviate their motor fluctuations that are commonly experienced with levodopa (the best drug we have so far in Parkinson’s) in the moderate to advanced stages of the disorder," Fernandez told Fox News Digital.

"This global, multi-center, pivotal trial showed that patients placed on tavapadon had significantly more ‘on time’ and less ‘off time’ compared to those who received placebo — and that the drug was well-tolerated by patients."

In the study, the researchers measured patients’ impulse control behavior disorders, excessive daytime sleepiness, blood pressure changes and weight changes, and found that the adverse effects linked to tavapadon were no different from those who received a placebo.

"Of course, this is a short-term study, and we need to wait for our long-term study to be really confident that our preliminary observations remain true," Fernandez noted. "Nonetheless, we are very encouraged."

The researchers presented the results of the TEMPO 3 trial at the American Academy of Neurology (AAN) earlier this month in San Diego.

For those who were recently diagnosed and are having less severe motor symptoms, Fernandez suggested that a once-daily dose of tavapadon could potentially replace the three-times-a-day dosing of levodopa.

"Should they require levodopa at some point, they will need a lower dose and less frequency, which then reduces their likelihood of developing motor fluctuations and dyskinesia and other side effects," he noted in a press release.

For those with more advanced Parkinson’s, tavapadon could be paired with levodopa. 

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"So regardless of when it’s used, whether in the very beginning or as an adjunctive therapy to levodopa, we think it’s a gain overall," Fernandez added.

Recent research has found that Parkinson's cases are expected to surge by 2050, affecting up to 25 million people globally.

The biggest increase will affect people aged 80 and older, with cases in that age group projected to increase by 196% by 2050, they noted. 

As results of the long-term trial are pending, AbbVie, the maker of tavapadon, will soon file an application to the Food and Drug Administration for approval of the drug.

"The FDA will then review the application — from there, they can either approve it for use, ask more questions that may not be clear, or request another study or an extension to verify some results," Fernandez said.

"We are hopeful that this new generation of dopamine agonist — being more selective in its dopamine receptor stimulation, and given only once daily — will be a significant improvement in the symptomatic treatment of PD symptoms in the early, middle and advanced stages of the disease," he added. 

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Dr. Mary Ann Picone, medical director of the MS Center at Holy Name Medical Center in Teaneck, New Jersey, was not involved in the study but called the results "very interesting and encouraging as a new tool for improving quality of life for patients with Parkinson's disease."

"One of the major limitations of the long-term use of dopamine is wearing-off phenomena and the need to dose it more frequently," Picone told Fox News Digital. 

"The use of dopamine agonists helps to prolong the long-term benefit of dopamine. Decreased benefit of dopamine can lead to ‘freezing,’ or episodes where patients have increased stiffness and difficulty moving."

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"This new therapy would target different receptors and allow for more ‘on’ time, but without the involuntary dyskinesia (uncontrolled movements) that … can interfere with function."