At the American Academy of Neurology (AAN) 2024 Annual Meeting, further data on AbbVie’s Produodopa/Vyalev and NeuroDerm’s ND0612 (levodopa/carbidopa) were showcased for the treatment of Parkinson’s disease (PD) in anticipation of their US approvals later this year.
These innovative levodopa delivery systems offer an improved route of administration, increased control of motor symptoms over the long term, and have a positive impact on patients’ quality of life (QoL).
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Innovation in drug formulations and delivery systems is one of the most rapidly changing areas in PD treatment and is primarily driven by the levodopa market.
The new delivery systems offer a 24-hour continuous subcutaneous infusion of levodopa and are proposed to improve the rate of compliance while reducing the risk of motor fluctuations and levodopa-induced complications such as levodopa-induced dyskinesia and ‘off’ episodes.
Key opinion leaders (KOLs) previously interviewed by leading data and analytics company GlobalData stated that patients with severe motor fluctuations would especially benefit from continuous dopaminergic therapy.
At the AAN 2024 Annual Meeting session titled ‘Movement Disorders: Clinical Trials in Movement Disorders’, NeuroDerm presented further efficacy data and a subgroup analysis from a randomised controlled Phase III study (BouNDless; NCT04006210).
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By GlobalDataThe study showed that treatment with an optimised ND0612 regimen (optimal regimens for both immediate-release [IR] levodopa [LD]/carbidopa [CD] and ND0612 infusion, with supplemental oral LD/CD, were established in an open-label run-in phase [less than 12 weeks]) provided an additional 1.72 hours of ‘on’ time without troublesome dyskinesia compared with IR-LD/CD (p<0.0001).
The study also evaluated the efficacy and safety of ND0612 for different subgroups of PD patients experiencing motor fluctuations.
A subgroup analysis demonstrated a homogeneous treatment effect in relation to ‘on’ time improvements and minimal differences in the safety and tolerability of ND0612 across the different analysed subgroups, including age, sex, body mass index, and geographical region, suggesting wide adoption potential for the drug in all advanced PD patients with severe motor fluctuations.
At the AAN 2024 Movement Disorders Poster session, AbbVie presented the long-term safety and tolerability of Produodopa/Vyalev (NCT04379050) from an open-label extension (OLE) study of advanced PD patients who had previously completed a parent trial – a 52-week, open-label Phase III study (NCT03781167).
KOLs previously interviewed by GlobalData emphasised that the success of levodopa infusion systems required the avoidance of infusion-site reactions and reduced discontinuation rates due to safety and tolerability issues.
The OLE outcomes addressed some of these concerns through the demonstration of a long-term favourable safety profile.
Overall, 83.7% of patients experienced ≥1 adverse events (AEs), with infusion site erythema and cellulitis being two of the most common AEs experienced by 16.3% and 15.5% of patients, respectively.
Treatment-related improvements in QoL scores, ‘off’ and ‘on’ times, and morning akinesia observed at the conclusion of the 52-week parent study were also maintained throughout the OLE.
Produodopa/Vyalev was launched in Germany, Spain, the UK, and Japan in 2023, and in France, Germany, Italy, Spain, and Canada in early 2024, making it the first subcutaneous 24-hour infusion of levodopa to be approved for the treatment of advanced PD with severe motor fluctuations.
However, its US launch hit a snag when it received a complete response letter in March 2023.
NeuroDerm’s ND0612 is anticipated to launch in the US market later this year with a Food and Drug Administration Prescription Drug User Fee Act date in the second quarter of 2024, meaning that it could beat AbbVie in the race to US commercialisation.
However, if both products receive US approval, real-world evidence and longer-term follow-up data could provide a competitive edge in the absence of a head-to-head trial comparing Produodopa/Vyalev and ND0612.
