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Abstract Details

CVT-301 (Levodopa Inhalation Powder): Meta-Analysis of Safety in Patients With Parkinson’s Disease (PD)
Movement Disorders
Movement Disorders Posters (7:00 AM-5:00 PM)
141

To investigate combined safety results from 3 trials of CVT-301 for the treatment of OFF episodes in PD patients on an oral dopa-decarboxylase inhibitor/levodopa (DDI/LD) regimen.

In a phase 3, double blind study, CVT-301 84mg improved motor function in PD patients with OFF periods at week 12, as measured by Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III) scores. More patients achieved and maintained an ON state within 60 minutes postdose vs placebo. CVT-301 was generally well tolerated. Safety results from this study were combined with results from a 4-week, phase 2b, double blind, placebo-controlled study and a 12-month safety study of CVT-301 compared to an observational cohort (OC) control.

Patients were receiving oral DDI/LD, experiencing > 2 hours/day of OFF periods and randomized to CVT-301 (60mg or 84mg; only the 84mg is included in this analysis) or placebo or OC (no study drug administered), to be taken up to 5 times/day when subjects experienced return of OFF symptoms. Safety measurements included treatment-emergent adverse events (TEAEs), and serious AEs (SAEs). Risk differences (RD) were compared between treatments by meta-analysis.
The combined safety population was 709 patients. Combined study TEAEs were higher in CVT-301, but were not significantly different vs placebo or OC (RD 0.074, 95%CI -0.058, 0.206). SAEs and AEs leading to discontinuation showed no significant difference between groups (RD 0.003, 95%CI -0.031, 0.038[SAE]; RD 0.031, 95%CI -0.035,0.098[discontinuation]). Severe and drug-related TEAEs were higher in the CVT-301 group, but differences were not significant (RD 0.021, 95%CI -0.027, 0.069[severe]; 0.185 95%CI -0.038, 0.409[drug-related]). Respiratory system AEs were higher in CVT-301, but not significantly (RD 0.073, 95%CI -0.065, 0.211). Additional data will be presented.
Overall, TEAEs, SAEs and AEs leading to discontinuation were not significantly different in frequency between CVT-301 and placebo/OC groups, demonstrating that CVT-301 is generally safe and well tolerated.
Authors/Disclosures
Peter A. LeWitt, MD (Henry Ford Hospital - Franklin Pointe)
PRESENTER 		Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. LeWitt has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ONO Pharmaceuticals. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. The institution of Dr. LeWitt has received research support from Michael J Fox Foundation.
No disclosure on file
Ann E. Corbin, DHSc, MS (Ipsen) Dr. Corbin has received personal compensation for serving as an employee of Ipsen Biopharmaceuticals. Dr. Corbin has or had stock in Ipsen Biopharmaceuticals .
Deena M. Kegler-Ebo, PhD (Neurelis, Inc.) Dr. Kegler-Ebo has received personal compensation for serving as an employee of Acorda Therapeutics. Dr. Kegler-Ebo has received stock or an ownership interest from Acorda Therapeutics.
Burkhard Blank Burkhard Blank has received personal compensation for serving as an employee of Acorda Therapeutics. Burkhard Blank has received stock or an ownership interest from Acorda Therapeutics, Inc.