Remaining Questions and Next Steps for Parkinson Agent P2B001: Lawrence Elmer, MD, PhD; Cheryl Fitzer-Attas, PhD
The medical director of the Center for Neurological Disorders at the University of Toledo discussed positive phase 3 findings assessing P2B001, and how the agent would potentially fit in the Parkinson treatment landscape. [WATCH TIME: 4 minutes]
WATCH TIME: 4 minutes
"If we start using this on a regular basis in our newly diagnosed patients with Parkinson disease, how long will they be able to be controlled with this tolerable agent? Once a day pill, no titration. Can they go 7-9 years? Could they go longer? I don’t know, we’ve had other suprises."
Although there are no disease-modifying therapies available, Parkinson disease (PD) has been typically managed through carbidopa levodopa and a number of other medicines. These include dopamine agonists to stimulate the production of dopamine in the brain, enzyme inhibitors to increase the amount of dopamine by slowing down the enzymes that break it down, amantadine, which helps reduce involuntary movements, and anticholinergic drugs, used to reduce tremors and muscle rigidity.
Pramipexole, a dopamine agonist sometimes used in combination with other medications or alone, is another treatment for symptoms of PD. At the 2023 American Academy of Neurology (AAN) Annual Meeting, held April 22-27, in Boston, Massachusetts, new phase 3 data highlighted the therapeutic potential of P2B001, a low dose combination of extended-release pramipexole (Prami-ER) and rasagiline, a monoamine oxidase type B inhibitor. At the end of a 12-week treatment period, changes in Unified Parkinson’s Disease Rating Scale Part II and III scores combined were between P2B001 and Prami-ER were not significantly different (–8.35 [±0.86] vs 7.98 [±0.6]), with noninferiority confirmed in post-hoc analysis (margin of 3 points; P = .0052).
Pharma Two B, the drug manufacturer for P2B001, plans to submit a new drug application to the FDA in 2023. To learn more about the future plans of the agent, as well as unanswered questions, NeurologyLive® sat down with Lawrence Elmer, MD, PhD, medical director, Center for Neurological Disorders, University of Toledo, and Cheryl Fitzer-Attas, PhD, MBA, head of medical affairs at Pharma Two B. The duo provided insight on the unique benefits of the agent, including its reduced rate of sleep-related and dopaminergic adverse events, as well as how it would fit into the treatment landscape for PD if approved.
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