Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and H. Lundbeck A/S announced today that a double-blind, placebo controlled, randomized, multicenter study of Azilect ® (rasagiline tablets) met its primary endpoint. The study, known as ANDANTE ( Add o N to Dopamine Ago Nists in the Tr Eatment 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 its indication as adjunct therapy to levodopa), its 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 significant 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 significant difference in adverse events compared to placebo.
“The positive outcome of this study is important news for the PD community, for patients and physicians,” said Robert A. Hauser, M.D., M.B.A., Director, Parkinson’s Disease & Movement Disorders Center at the University of South Florida and primary investigator of the study. “In addition to rasagiline providing symptomatic benefit to patients sub-optimally controlled with dopamine agonist monotherapy, the study confirmed that rasagiline is well-tolerated and provided proof-of-concept for adding rasagiline to dopamine agonist therapy.”
As a monoamine oxidase B (MAO-B) inhibitor, Azilect acts by increasing available synaptic dopamine. This mode of action provided the rationale for add-on therapy to dopamine agonists in the management of PD.“The ANDANTE data continue to clarify the clinical profile of Azilect and the role it plays in helping to meet the needs of those living with PD, at multiple points in the progression of their disease,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “Teva is committed to the continued research and understanding of Azilect in PD and to sharing important findings like these with the scientific community.”