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Sustained-Release Pramipexole/Rasagiline Combo Shows Promise in Parkinson’s Patients

Treatment meets both primary and secondary endpoints in mid-stage study

Positive results have been reported from a phase IIb trial of P2B001 (Pharma Two B Ltd.) for the treatment of early-stage Parkinson’s disease (PD). P2B001 is a combination of pramipexole and rasagiline administered as a proprietary sustained-release formulation. The study met primary and secondary clinical endpoints for both high-dose and low-dose combinations.

Specifically, results from the 12-week, randomized, double-blind, placebo-controlled, parallel-group study showed an overall improvement of 5.97 points on the Unified Parkinson's Disease Rating Scale (UPDRS) for the high-dose combination, leading to a significant change of 4.67 UPDRS points compared with placebo (P < 0.001). The results also showed an overall improvement of 5.14 UPDRS points for the low-dose combination, leading to a significant change of 3.84 UPDRS units compared with placebo (P < 0.001).

A total of 149 patients with PD participated in the study, which was conducted at clinical sites in the U.S. and Israel.

An estimated 7 to 10 million people worldwide have PD. The cardinal symptoms of the disease include tremors, bradykinesia, rigid or stiff muscles, and impaired posture, balance, and walking.

The current gold standard for the treatment of PD is levodopa, but long-term use of this drug is associated with severe adverse effects over time, including dyskinesia (uncontrolled involuntary movements) and “off” periods (hours when the patient experiences the return of parkinsonian features). For this reason, physicians often prescribe other drugs at the early stage of the illness to delay the introduction of levodopa. Although alternative treatments are not associated with motor complications, they are not as effective as levodopa and can also result in serious adverse effects. Therefore, there is an unmet medical need for a safe and effective treatment of early PD that allows a delay in the introduction of levodopa and in the risk of levodopa-associated motor complications.

Source: PR Newswire; June 30, 2015.

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