Pramipexole and rasagiline combo first line treatment for parkinsons

Parkinson's disease (PD) is a brain disorder that leads to shaking, stiffness, and difficulty with walking, balance, and coordination. Parkinson's symptoms usually begin gradually and get worse over time.

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.

An experimental drug that combines fixed doses of extended-release (ER) formulations of existing medications can significantly reduce symptoms in patients with untreated early-stage PD, new research suggests. The findings were presented at the American Academy of Neurology (AAN) 2022 Annual Meeting.

Researchers used 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 to have synergistic effects. Tracing the 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).