Onerji(levodopa / carbidopa)

Onerji (levodopa / carbidopa) is a solution for infusion, with strengths of 60 mg/ml levodopa and 7.5 mg/ml carbidopa. It is developed by Tanabe Pharma GmbH and has the ATC code N04BA02. The regulatory product number is EMEA/H/C/006429.

In clinical studies, Onerji (ND0612) demonstrated a reduction in OFF time of 2.1 hours compared to 1.4 hours for placebo. When compared to oral immediate-release levodopa/carbidopa (Oral IR-LD/CD), Onerji showed a change from baseline to V19/DBW12 in "GOOD ON" time of 1.72 hours (p<0.0001) and a change in "OFF" time of -1.40 hours (p<0.0001). It also resulted in a change from baseline in "ON" time without dyskinesia of 2.12 hours. The odds ratio for improvement in PGIC scores was 5.31 (95% CI: 2.67, 10.58; p<0.0001) and for CGI-I scores was 7.23 (95% CI: 3.57, 14.64; p<0.0001) compared to Oral IR-LD/CD.

Safety data from the pivotal study (ND0612-317) with 381 subjects showed a discontinuation rate of 6.3% in the ND0612 arm and 6.1% in the IR-LD/CD arm. Discontinuations due to adverse events were 7 subjects in the ND0612 arm and 4 subjects in the IR-LD/CD arm. One subject (0.3%) discontinued during the conversion period due to dopaminergic adverse events.