- CVT-301 Phase 3 SPAN-PD study met primary endpoint of improvement in UPDRS III, in data presented at 2017 International Congress of Parkinson’s Disease and Movement Disorders (MDS)
- Multiple secondary endpoints were supportive of primary endpoint result
- Acorda plans to file New Drug Application (NDA) in U.S. by end of Q2 2017
- Company to host investor webcast to review data from CVT-301 clinical program on Monday, June 5 at 4:30 pm Eastern / 1:30 pm Pacific
ARDSLEY, N.Y.--(BUSINESS WIRE)--Acorda Therapeutics, Inc. (Nasdaq:ACOR) presented data from its Phase 3 SPAN-PD clinical trial of CVT-301 (levodopa inhalation powder) that showed a statistically significant, clinically meaningful improvement in motor function, as measured by the Unified Parkinson’s Disease Rating Scale – Part III (UPDRS III) in people with Parkinson’s experiencing OFF periods. Multiple secondary endpoints, including achievement of an ON state with maintenance through 60 minutes and Patient Global Impression of Change (PGIC), were supportive of the primary endpoint result. These findings are being presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS), being held in Vancouver, British Columbia from June 4-8, 2017.
Acorda is developing CVT-301 as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa / levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms.
Key Efficacy and Safety Findings: Phase 3 SPAN-PD Study
The poster “Inhaled levodopa (CVT-301, 84-mg dose) significantly improves motor function during OFF periods in Parkinson’s disease subjects: A Phase 3 Study (SPAN-PD)” (Poster #LBA34) highlighted findings from a 12-week, placebo-controlled trial that enrolled 339 participants.
The study met its primary endpoint, with CVT-301 84 mg showing statistically significant improvement in motor function compared to placebo as measured by mean change in the UPDRS III at 30-minutes post-dose at Week 12 (-9.83 vs. -5.91; p = 0.009).
Secondary efficacy analyses were performed using a pre-specified hierarchy. The order of hierarchy was set based on probability of success, guided by the Phase 2b results. The primary endpoint (CVT-301 84 mg vs. placebo) was tested first for statistical significance. Upon achieving significance, the secondary endpoints were tested for CVT-301 84 mg vs. placebo followed by CVT-301 60 mg in the hierarchical order, as long as each preceding endpoint reached a significance level of P < 0.05. The hierarchical sequence did not reach statistical significance at Step 3. Unadjusted (nominal) p-values are presented below for all key secondary endpoints.
