In the Phase 3 ARISE trial, once-daily oral solengepras 150 mg reduced average daily OFF time by 0.61 hours versus placebo at week 12 and increased ON time without troublesome dyskinesia by 0.60 hours in people with Parkinson's disease and motor fluctuations. Secondary measures including daily function (MDS-UPDRS Part II), daytime sleepiness and quality of life also favored the active arm, with 91% trial completion and a 3.5% discontinuation rate due to adverse events. Cerevance plans to discuss a New Drug Application with the FDA.
Key Points
- Solengepras 150 mg cut daily OFF time 0.61 hours versus placebo
- ON time without troublesome dyskinesia rose 0.60 hours
- Function, sleepiness and quality-of-life scores improved; tolerability favorable
Longevity Analysis
Motor fluctuation management in Parkinson's determines how many hours per day a person can move, work and remain independent, making functional time a more meaningful endpoint than symptom scores alone. An adjunctive agent that extends usable ON time without adding troublesome dyskinesia addresses a persistent trade-off in dopaminergic therapy, where added benefit often arrives with movement side effects. Improvements in daytime alertness and self-reported daily function point to effects that reach beyond motor control into the broader architecture of arousal and quality of life — and the once-daily oral format lowers the adherence burden that typically erodes long-term benefit.
Original published by LT Wire.