A novel combination of Pramipexole-Rasagiline is found to be promising in a recently concluded clinical trial for Early Parkinson Disease treatment. Top line results from this Phase III trial indicate the superiority of fixed-dose combination of extended release (ER) formulations of pramipexole and rasagiline (P2B001) in adults with early Parkinson disease. P2B001 has successfully met its endpoints, both primary and secondary. The ER combination of pramipexole and rasagiline is compared with pramipexole ER and rasagiline ER when given as single agents. Clinical trial outcomes affirm the potential of P2B001 for becoming an emerging treatment option to treat Early Parkinson Disease.
Advancements in the Management of Parkinson’s disease
Parkinson Disease is a neurodegenerative disorder that mostly affects the elderly. It is characterized by symptoms such as tremor of the hands and legs, jaw and face are also impacted. With the symptoms worsening with time, quality of life of the patients is mostly reduced. When it comes to the treatment of Parkinson’s, it is mostly focused on management of the symptoms. There are no curative therapies available at present. Among the available options, levodopa is the most commonly recommended treatment. It is indeed referred as the gold standard treatment for PD. There has been a significant gap in the treatment needs and available options. The novel combination with promising results can be considered as a significant progress in this therapeutic area.
In the Phase III clinical trial, once daily administration of Pramipexole (0.6mg)-Rasagiline (0.75mg) combination is compared with three other single agent regimens. 544 patients were randomized to one of the four treatment arms. The other three arms are pramipexole ER capsule 0.6 mg once daily, rasagiline ER capsule 0.75 mg once daily and the currently marketed product pramipexole ER capsules titrated to an optimal dose for each individual patient (1.5 to 4.5 mg) (Inputs from Medscape).Based on the Unified Parkinson Disease Rating Scale (UPDRS), it is determined that the combination arm is superior to the other there comparator arms. Superior advantage over administering increased doses of dopamine agonists is clearly demonstrated. The combination therapy could also alleviate commonly known side effects that include somnolence, orthostatic hypotension and hallucinations.
About Pharma Two B
It is an innovative clinical-stage pharmaceutical company. They have a unique approach towards developing value based products. They develop products based on the reformulation of approved drugs. The company’s focus is in the segment of neurological disorders and is now known for its work in the PD therapeutic area. They have made a significant headway in their mission of Optimizing Treatment for Parkinson’s disease. More information can be found on their official website www.pharma2b.com.
