The following article is part of conference coverage from the American Academy of Neurology (AAN) 2021 Virtual Annual Meeting. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from the AAN 2021 Virtual Annual Meeting.
Amantadine extended release capsules (ADS-5102) significantly increases ON time without dyskinesia in patients with Parkinson disease, according to study results presented at the American Academy of Neurology 2021 Virtual Annual Meeting, held April 17 to 22, 2021.
Previous studies have shown that ADS-5102, the only FDA-approved medication for levodopa-induced dyskinesia in Parkinson disease, was associated with significantly reduced troublesome dyskinesia and OFF time.
The objective of this post-hoc analysis of pooled pivotal trials was to determine the proportion of patients who reduced their total time with dyskinesia by 25%, 50%, 75%, and 100%, and spent minimums of 25%, 50%, 75%, and 100% of their waking day ON without troublesome dyskinesia and without any dyskinesia at week 12.
The sample included 165 participants who completed home diaries for 48 hours prior to scheduled visits. At week 12, a reduction in total dyskinesia time of at least 50% and at least 75% was reported for 53% and 27%, respectively, of patients treated with ADS-5102, compared with 26% (P =.001) and 14% (P =.04), respectively, for those receiving placebo.
Treatment with ADS-5102 was associated with a higher rate of patients reporting waking days ON without any dyskinesia at week 12, compared with placebo (13% vs 7%, respectively; P =.22).
At Week 12, more patients treated with ADS-5102 than placebo spent at least 50% of the waking day ON without either troublesome dyskinesia or OFF (91% vs 71%, respectively) or without any reported dyskinesia or OFF (56% vs 23%, respectively). Similarly, more patients treated with ADS-5102 than placebo spent at least 75% and 100% of the waking day ON without either troublesome dyskinesia or OFF (56% vs 28%; and 17% vs 1%; respectively) or without any reported dyskinesia or OFF (22% vs. 8% and 4% vs. 0%, respectively).
“These post-hoc analyses demonstrate a robust effect of ADS-5102 in increasing time spent ON without dyskinesia,” concluded the study researchers.
Hauser R, Pawha R, Walsh R, Lytle J, Formella A. ADS-5102 significantly increases ON time without dyskinesia: pooled patient diary analyses from Parkinson’s disease pivotal trials. Presented at the American Academy of Neurology 2021 Virtual Annual Meeting; April 17-22, 2021. Abstract P14.128