Standards of care in this space are predominantly mature brands with decades of clinical use and physician familiarity, with levodopa products continuing to dominate the market. Prescriptions for generic products constitute the vast majority of market volume. All approved therapies for Parkinson's disease (PD) are symptomatic treatments. 

There have been an array of impactful events in the PD space within the last 18 months. Amneal submitted an NDA to the FDA for its novel carbidopa/levodopa asset IPX203 in August 2022, but received a complete response letter (CRL) in July 2023. The company was instructed to run another trial and is aiming to resubmit the NDA in early 2024. In 2022, AbbVie filed an NDA for its subcutaneous foslevodopa/foscarbidopa drug ABBV-951 in advanced PD. The company received a CRL in March 2023 and is aiming to resubmit the NDA as soon as possible. ABBV-951 has been launched in Japan (as Vyalev) and in the UK (as Produodopa). Additionally, positive pivotal Phase III data were released for NeuroDerm’s ND0612 in January 2023, and are expected to be included in an NDA submission. NeuroDerm has not given a recent update on the timeframe for this submission. 

This Datamonitor Healthcare report contains a Disease Analysis module.