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Teva Pharmaceutical Industries Ltd And H. Lundbeck A/S Announces Results Of Azilect


Wednesday, 20 Mar 2013 07:16am EDT 

Teva Pharmaceutical Industries Ltd and H. Lundbeck A/S announced that a double-blind, placebo controlled, randomized, multicenter study of Azilect (rasagiline tablets) met primary endpoint. The study, known as ANDANTE (Add oN to Dopamine AgoNists in the TrEatment of Parkinson's disease), assessed the efficacy and tolerability of Azilect as add-on treatment to dopamine agonists compared to placebo. While the efficacy of Azilect as adjunct to levodopa has been established in previous studies (leading to indication as adjunct therapy to levodopa), efficacy in combination with dopamine agonist monotherapy has not previously been studied. Results from the study demonstrated that the addition of Azilect 1mg/day provided a statistically improvement (Primary endpoint: treatment effect ± SE -2.4 ± 0.95 [95% CI -4.3,-0.5, p=0.012]) in total Unified Parkinson's Disease Rating Scale (UPDRS) score (Parts I, II and III, version three) from baseline to week 18 in patients sub-optimally controlled with dopamine agonist monotherapy compared to placebo. Azilect was well-tolerated with no difference in adverse events compared to placebo. 

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