As AbbVie and NeuroDerm race toward potential U.S. approvals later this year, the companies presented strong data at last week’s American Academy of Neurology 2024 annual meeting for their respective continuous subcutaneous levodopa infusions.
With potential U.S. approvals on the line in Parkinson’s disease later this year, AbbVie and NeuroDerm presented promising data for their respective continuous, subcutaneous levodopa infusions at last week’s American Academy of Neurology 2024 annual meeting.
Both companies are developing novel delivery systems that allow 24-hour continuous subcutaneous delivery of their drug candidates, which according to Erela Dana, director of neurology at data analytics firm Global Data, could “improve the rate of compliance while reducing risk of motor fluctuations and levodopa-induced complications.”
At AAN24, AbbVie showed that its investigational subcutaneous treatment foslevodopa/foscarbidopa could elicit significant improvement in “on” time without troublesome dyskinesia in patients younger than 65 years of age. In Parkinson’s disease, on time refers to periods of good symptom control.
However, in those aged 65 years and older, the effect of foslevodopa/foscarbidopa was “numerical” and failed to reach statistical significance, according to AbbVie’s AAN24 abstract.
In all other patient subgroups, foslevodopa/foscarbidopa also led to “numerical improvements” in on time without troublesome dyskinesia and “off” time, which refers are the periods when symptoms grow more noticeable and difficult to manage.
According to GlobalData, AbbVie also presented long-term safety and tolerability data for foslevodopa/foscarbidopa from an open-label study. Results showed that nearly 84% of treated patients developed at least one adverse event, the most common of which were infusion site erythema and cellulitis.
“The success of levodopa infusion systems requires avoidance of infusion-site reactions and reduced discontinuation rates due to safety and tolerability issues,” Dana said, adding that AbbVie’s data “addresses some of these concerns.”
AbbVie is developing foslevodopa/foscarbidopa—a combination of prodrugs of levodopa and carbidopa, respectively—for the treatment of motor disturbances in adult patients with advanced Parkinson’s disease. In March 2023, the FDA hit the drug candidate with a Complete Response Letter, requesting additional information regarding its pump system. AbbVie at the time said it planned to resubmit the application.
At AAN24, NeuroDerm also presented data from a subgroup analysis of its Parkinson’s disease candidate ND0612, which improved on time without troublesome dyskinesia and had an “overall homogenous” effect when disaggregating patients according to age, sex, baseline disease severity and other factors.
Overall, ND0612 was able to improve on time without troublesome dyskinesia by 1.72 hours, according to NeuroDerm’s AAN24 abstract.
ND0612 is a drug-device combination therapy that allows the continuous infusion of a levodopa/carbidopa mixture. The investigational product is being developed to treat motor fluctuations in Parkinson’s disease and has a target action date in the second quarter of 2024.
While NeuroDerm could beat AbbVie in the race to U.S. commercialization, Dana notes that if both products receive FDA approval real-world evidence and longer-term follow-up data “could provide a competitive edge in the absence of a head-to-head trial.”
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
