Here is a list of commonly asked questions about P2B001
Q: What is P2B001?
A: P2B001 is a novel, investigational oral, once-daily, fixed-dose, extended-release (ER) combination of a low-dose, selective dopamine agonist, pramipexole 0.6mg and a low-dose, selective, irreversible Monoamine Oxidase-B (MAO-B) inhibitor, rasagiline 0.75mg. Both low doses are not currently available on the market and rasagiline ER is a new and proprietary formulation.
Q: At what stage of clinical development P2B001 is?
A: P2B001 has completed successfully pre-clinical, Phase IIb and Phase III studies which demonstrated significant clinical benefits in improving PD motor symptoms with a generally well tolerated safety profile and a low risk of dopaminergic side effects compared to PramiER. The New Drug Application (NDA) is planned to be submitted to the FDA in the near future. Press here, for more on P2B001 clinical evidence & safety.
Q: What are the key potential clinical benefits of P2B001?
A: P2B001 is an investigational product and has not been determined to be safe or effective by any regulatory authority. Results from the Phase IIb and Phase III clinical studies have shown that P2B001 has:
- Comparable symptomatic efficacy to higher doses of marketed pramipexole ER with significantly less daytime sleepiness and less dopaminergic side effects
- Superior symptomatic efficacy compared to its individual components (Total-UPDRS scores)
- Superior to its individual components in Activities of Daily Living (ADL) and Motor scores of the UPDRS
- Superior symptomatic efficacy compared to placebo control (Phase IIb)
- Convenient once-daily dosing with no need for titration
If approved, P2B001 has the potential to become a leading treatment option for people with PD, particularly as first line therapy that may delay time to levodopa and the accompanying risk of motor complications for early-stage patients of all ages.
Q: What are possible adverse reactions of P2B001?
A: P2B001 is an investigational product and has not been determined to be safe or effective by any regulatory authority. The safety and tolerability profile of P2B001 was established in both the Phase IIb and Phase III clinical studies, involving 693 patients in total.
More than 98% of the treatment-emergent adverse events (TEAEs) were mild or moderate in severity. Phase 3 results demonstrated fewer treatment-realted adverse events with P2B001 vs. pramipexole-ER. For detailed information, press here, for more on P2B001 safety.
Q: What are the treatment options for early PD patients?
A: Early Parkinson’s patients need a treatment option that can significantly improve their motor symptoms and daily function, while avoiding impairing side effects. Three main therapeutics are currently available to treat early PD:
- Levodopa, recommended as first line treatment. However, most patients develop motor complications, such as fluctuations and dyskinesia, typically within 3-5 years after treatment initiation. In addition, Levodopa administration requires multiple doses per day and titration is required, necessitating multiple physician visits
- Dopamine agonists, effective in relieving motor function symptoms. Side effects include daytime sleepiness, hallucinations, impulse control disorders, orthostatic hypotension, constipation and nausea. In addition, titration is required.
- MAO-B inhibitors are considered better tolerated but with limited efficacy as monotherapy. They are well tolerated with few side effects though may lead to serotonin syndrome if concomitant medications are not monitored.
Q: Have any P2B001 data been published?
A: Yes, there have been a few publications on P2B001:
- Olanow CW et al. A randomized trial of a low-dose Rasagiline and Pramipexole combination (P2B001) in early Parkinson’s disease. Mov Disord. 2017 May;32(5):783-789. doi: 10.1002/mds.26941.
- Hauser RA et al. P2B001 (Extended Release Pramipexole and Rasagiline): A New Treatment Option in Development for Parkinson’s Disease. Adv Ther. 2022 May;39(5):1881-1894. doi: 10.1007/s12325-022-02097-2.
- Olanow WG. Efficacy and safety of P2B001 in the management of early Parkinson’s disease. Results from a phase 3, randomized, double-blind, double-dummy controlled trial. Presented at: AAN Annual Meeting; April 2-7, 2022; Seattle, WA, and virtual. Abstract 011.