Israel-based Teva Pharmaceutical Industries has announced positive results of its Phase III Adagio trial.

The Adagio study showed that Parkinson's disease (PD) patients who took Azilect (rasagiline) 1mg tablets once-daily upon entry into the trial demonstrated a significant improvement compared to those who initiated the drug nine months later. The 1mg dose met all three primary endpoints, as well as the secondary endpoint, with statistical significance.

Adagio is a randomized, multi-center, double-blind, placebo-controlled, parallel-group study prospectively examining rasagiline's potential disease-modifying effects in 1,176 patients with early, untreated PD. Patients from 129 centers in 14 countries were randomized to early-start treatment (72 weeks rasagiline 1mg or 2mg once daily) or delayed-start treatment (36 weeks placebo followed by 36 weeks rasagiline 1mg or 2mg once daily [active treatment phase]).

The primary analyses of the trial were based on change in total unified Parkinson's disease rating scale and included slope superiority of rasagiline over placebo in the placebo-controlled phase, change from baseline to week 72, and non-inferiority of early-start versus delayed-start slopes during weeks 48-72 of the active phase. The safety profile of Azilect seen in the Adagio study was similar to previous experience with Azilect, said Teva.

Teva intends to submit the results to the regulatory authorities in the US and Europe. Based on these results, Teva will work with the regulatory authorities to incorporate the results into the label for Azilect.