EU approves Numient (Levodopa and Carbidopa) for adult patients with Parkinson's disease- Impax Labs

Impax Laboratories has announced that the European Commission (EC) has granted marketing authorization for Numient (Levodopa and Carbidopa), a modified-release oral capsule formulation for the symptomatic treatment of adult patients with Parkinson's disease. The EC decision is based on results from three Phase III controlled clinical studies which assessed the safety and efficacy of Numient in patients with early (levodopa-naive) and advanced Parkinson's disease in the U.S. and in Europe.

The APEX-PD study met its primary efficacy endpoint of mean change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) score and UPDRS Part III (motor examination) score for NUMIENT versus placebo at end of study. The ADVANCE-PD trial showed treatment with Numient reduced the percentage of "off" time (36.9% to 23.8%) from baseline versus immediate-release levodopa-carbidopa (36.0% to 29.8%) during waking hours to end of study, representing almost 1.2 hours of additional "off" time improvement. The ASCEND-PD trial found that patients had "off" time of 24.0% (3.8 hours) during waking hours compared to 32.5% (5.2 hours) for LCE (p<0.0001), representing 1.4 hours of additional "off" time improvement.