P2B001 is a novel, once-daily combination of extended-release (ER) pramipexole, a low dose dopamine agonist (0.6mg), and rasagiline, a low dose MAO-B inhibitor (0.75mg), developed specifically for the treatment of Parkinson’s Disease (PD). The low doses utilized in P2B001 are not currently available on the market and the ER formulation of rasagiline is a proprietary dosage form of Pharma Two B. The combination showed a significant increase in striatal dopaminergic transmission via distinct and potentially synergistic mechanisms in a mouse model and the extended-release profile resulted in a further increase in dopamine levels.
The combination at lower doses was developed to address an unmet need in PD patients who are in need of an effective treatment that does not have debilitating side effects, associated with Levodopa or dopamine agonists, and is taken once-daily without a need to titrate
P2B001 has been investigated in a robust development plan that included non-clinical studies, pharmacokinetic studies in healthy volunteers, a Phase IIb study involving 149 PD patients and a Phase III study involving 544 PD patients in 70 leading PD centers across USA, Europe and Canada. For more information on these completed studies, refer to ClinicalTrials.gov Identifier: Phase II: NCT01968460 and Phase III: NCT03329508
Data from both Phase II and Phase III studies with P2B001 suggest it may provide significant symptomatic benefits with less dopaminergic side effects, and a favorable safety profile.
P2B001 is an investigational product and is not currently approved by any regulatory authority.