New Data Sparks Levodopa Competition at AAN24

In anticipation of possible U.S. regulatory approvals for Parkinson’s disease treatments later this year, AbbVie and NeuroDerm have unveiled encouraging results for their innovative, continuous subcutaneous levodopa infusion therapies at the 2024 American Academy of Neurology's annual gathering.

AbbVie and NeuroDerm are both working on cutting-edge drug delivery systems that facilitate a non-stop, around-the-clock subcutaneous administration of their respective drug candidates. According to Erela Dana, a neurology expert at Global Data, a data analytics firm, these systems could potentially "enhance patient adherence, while minimizing the risk of motor fluctuations and complications caused by levodopa."

At the annual meeting, AbbVie demonstrated that its experimental subcutaneous treatment, foslevodopa/foscarbidopa, resulted in a significant extension of "on" time in patients under 65 years old, without causing bothersome dyskinesia. In Parkinson’s disease, "on" time is the period during which symptoms are well-managed. However, in patients aged 65 and above, the impact of foslevodopa/foscarbidopa was only "numerical" and did not achieve statistical significance, as per AbbVie’s presentation at the conference.

For all other patient groups, foslevodopa/foscarbidopa also led to "numerical improvements" in both "on" time without troublesome dyskinesia and "off" time, which refers to periods when symptoms become more pronounced and harder to handle.

GlobalData reported that AbbVie also presented data on the long-term safety and tolerability of foslevodopa/foscarbidopa from an open-label study. The findings indicated that nearly 84% of the patients treated experienced at least one adverse event, with the most prevalent being redness and inflammation at the infusion site.

Dana emphasized that the success of levodopa infusion systems hinges on avoiding reactions at the infusion site and reducing the rate of discontinuation due to safety and tolerability concerns. She added that AbbVie’s data "addresses some of these concerns."

AbbVie is developing foslevodopa/foscarbidopa, a combination of prodrugs of levodopa and carbidopa, to treat motor disturbances in adult patients with advanced Parkinson’s disease. In March 2023, the FDA issued a Complete Response Letter for the drug candidate, seeking additional information about its pump system. AbbVie had stated its intention to resubmit the application.

NeuroDerm also presented data at the conference from a subgroup analysis of its Parkinson’s disease candidate, ND0612, which improved "on" time without troublesome dyskinesia and showed a "consistent" effect across different patient demographics. According to NeuroDerm’s presentation, ND0612 was able to enhance "on" time without troublesome dyskinesia by 1.72 hours.

ND0612 is a drug-device combination therapy that enables the continuous infusion of a levodopa/carbidopa mixture, developed to address motor fluctuations in Parkinson’s disease, with a target action date set for the second quarter of 2024.

While NeuroDerm might outpace AbbVie in securing U.S. commercialization, Dana noted that if both products receive FDA approval, real-world evidence and longer-term follow-up data "could offer a competitive advantage in the absence of a direct comparison trial."