The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease
Shots:
- The US FDA has approved Onapgo injection (SPN-830; SC infusion device) to treat motor fluctuations in adults with advanced Parkinson’s disease; commercially available in Q2’25
- Approval was based on a 12wk P-III trial assessing Onapgo (n=53) vs PBO (n=51) in Parkinson’s pts (N=107), evaluating 1EP of mean change in total daily OFF time & 2EPs of mean change in daily GOOD ON time (ON time without troublesome dyskinesia) as well as PGIC
- Study showed reduction in daily OFF time at 12wks. (2.6 vs 0.9hrs.) & increase in daily GOOD ON time (2.8 vs 1.1hrs.), where improvements were seen as early as 1wk. with sustained results throughout. Benefits in general health (PGIC: 79% vs 24%) were also reported
Ref: Supernus | Image: Supernus
Related News:- Supernus Reports the US FDA’s Acceptance to Review SPN-830’s Resubmitted NDA for the Treatment of Off Episodes in Parkinson’s Disease
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
