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Novel Combo Drug Shows Promise as First-Line Parkinson’s Treatment

0 2 years ago

Results from a phase 3 trial of P2B001, a combination of pramipexole and rasagiline at currently unavailable low doses, showed the drug was more effective than its individual components and as effective as higher-dose pramipexole ER — with far less daytime sleepiness.

The combination drug is taken once a day and does not require titration, which investigators say make it a good option for first-line treatment of PD.

“I don’t think people, including me, expected intuitively that if you used small doses and combined it with a little rasagiline it would be equal to full doses of pramipexole, but it appears that it is,” lead investigator Warren Olanow, MD, professor and chair emeritus of neurology and professor emeritus of neuroscience at Icahn School of Medicine at Mount Sinai, New York City, told Medscape Medical News.

The findings were presented at the American Academy of Neurology (AAN) 2022 Annual Meeting.

“Synergistic Effects”

Levodopa is considered to be the most effective treatment for PD, but long-term use is associated with increased risk for motor complications, such as dyskinesia. Dopamine agonists such as pramipexole have been linked in previous research to excessive daytime sleepiness and impulse control disorders.

In addition, as reported by Medscape Medical News, monoamine oxidase-B inhibitors such as rasagiline are not as effective at controlling PD as other treatment options.

“There is no consistent agreement on how to initiate treatment because no one treatment is ideal,” Olanow said.

P2B001, developed by Pharma Two B, is a combination of 0.6 mg of pramipexole and 0.75 mg of rasagiline. The drugs work by dual mechanisms, which investigators suspected might have “synergistic effects.”

Following promising results from an earlier trial, researches launched a phase 3, 12-week, international, randomized, double-blind trial to study the efficacy, safety, and tolerability of P2B001 compared with its individual components and with a calibration arm of pramipexole ER in 519 patients with early PD.

Participants received P2B001, 0.6 mg of pramipexole ER, 0.75 mg of rasagiline ER, or pramipexole ER titrated to an optimal dose for each patient (1.5 to 4.5 mg).


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