Most common abuse-related AEs in the ≤3-month CVT-301 and placebo groups respectively were dizziness (2.2% vs 4.5%), hallucinations (1.5% vs 1.3%), and somnolence (0.7% vs 1.3%). In the 12-month group (CVT-301 vs OC) they were dizziness (2.4% vs 0.8%), hallucinations (2.2% vs 1.6%), and euphoric mood (0.3% vs 0%). Intentional oral levodopa misuse and DDS were recorded in 1 patient (0.2%) in CVT-301 12-month group. Abuse-related AEs led to 7 discontinuations in the CVT-301 groups (euphoric mood, product misuse, hallucination, visual hallucination, dizziness, DDS). Two patients (0.7%) in the ≤3-month and 9 (1.5%) in the 12-month CVT-301 groups used ≥8 doses/day (max permitted=5) on ≥1 day, while mean daily use remained ~2.0 doses/day over 12 months.

Abuse-related AE incidence for CVT-301 was low and similar to placebo/OC. Overutilization and discontinuation for abuse-related AEs remained low. CVT-301 does not appear to increase the risk of overuse beyond known risks associated with oral levodopa and is not a controlled substance.