The director of the James J. and Joan A. Gardner Family Center discussed data from the phase 3 BouNDlesstrial assessing a continuous, subcutaneous levodopa/carbidopa delivery system for patients with Parkinson disease experiencing motor fluctuations. [WATCH TIME: 3 minutes]
WATCH TIME: 3 minutes
"The hypothesis of the trial was that the infusion system would prolong the ON time with little or no dyskinesia compared to immediate release carbidopa levodopa. In fact, that’s what happened."
Parkinson disease (PD), a progressive neurodegenerative disorder characterized by tremors, has been typically treated with combination of treatments, most notably carbidopa levodopa (CD/LD), followed by other agents such as dopamine agonists and monoamine oxidase B (MAO) inhibitors. As efforts to develop disease-modifying therapies have been largely unsuccessful, several pharmaceutical companies have focused on more symptomatic therapies, including better ways of administering previously used treatments. Developed by NeuroDerm, ND0612 is a continuous, subcutaneous CD/LD delivery system that's shown a safe tolerability profile and sustained improvements in daily good ON time.
ND0612, is designed to improve the pharmacokinectic profiles of oral LD/CD by avoiding gastric involvement and maintaining stable and continuous therapeutic levodopa plasma concentrations. At the 2023 American Academy of Neurology (AAN) Annual Meeting, held April 22-27, in Boston, Massachusetts, 3-year outcomes from the pivotal phase 3 BeyoND trial (NCT02726386) were presented. Of the 114 patients who entered the open-label extension, 94 (82.5%) completed at least 2 years of treatment and 76 (66.7%) completed at least 3.
Led by Alberto J. Aspay, MD, MSc, the incidence of infusion-site infection decreased from 19.3 in year 1 to 9.9% in year 2, and 11.7% in year 3, while the incidence of other infusion-site reactions decreased from 60.5% in year 1, 26.1% in year 2, and 27.7% in year 3. Aspay, director of the James J. and Joan A. Gardner Family Center, sat down with NeurologyLive® at the meeting to discuss the OLE findings, and the take-home points the clinical community should be aware of. In addition, Aspay provided perspective on the advantages of this therapy and the role it might have if approved.