Date: Thursday, June 23, 2016
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: Describe the dosing patterns in advanced Parkinson’s disease (PD) patients who completed conversion to IPX066 from other levodopa formulations.
Background: IPX066 is an extended-release oral formulation of carbidopa-levodopa (CD-LD). Following an initial peak at about one hour, plasma LD concentrations are maintained for about 4-5 hours.
Methods: Two phase 3 studies examined the efficacy and safety of IPX066 vs. immediate-release (IR) CD-LD (ADVANCE-PD) and vs. CD-LD+entacapone (CLE; ASCEND-PD) in patients with advanced PD. In both studies, patients underwent a 6-week open-label conversion to IPX066 prior to treatment randomization. Conversion charts based on ranges of daily LD dose guided the initial dosing with IPX066. The final LD dose ratio from IPX066 vs. previous LD treatment, IPX066 dose frequency at the end of conversion, and the difference from the initial suggested IPX066 dose were examined overall and within high and low halves of each dose range on the conversion chart.
Results: In ADVANCE-PD, 393 (87.3%) patients completed conversion; 60% ended higher (median increase: 435 mg) and 16% ended lower (median decrease: 245 mg) than the recommended initial IPX066 dose. In ASCEND-PD, 91 (82.7%) completed conversion; 56% ended higher (median increase: 380 mg) and 13% ended lower (median decrease: 245 mg) than the recommended dose. Final mean dosing frequencies with IPX066 decreased to 3.5 (ADVANCE-PD) or 3.6 (ASCEND-PD) doses/day after conversion from 5.1 (IR) or 5.0 (CLE) doses/day prior to conversion. Final dose ratios tended to be higher for patients taking lower LD doses at study entry, while final IPX066 dose frequency tended to increase with increasing LD dose (Tables 1 and 2).
|IR CD-LD Dose at Study Entry (mg/day)||N||Final Mean (SD) LD Dose Ratio, IPX066:IR||Final Mean (SD) Dosing Frequency (doses/day)|
|400-550||126||2.4 (0.7)||3.3 (0.4)|
|551-750||100||2.1 (0.7)||3.5 (0.6)|
|751-950||74||2.1 (0.6)||3.7 (0.7)|
|951-1250||64||2.1 (0.6)||3.8 (0.8)|
|1251-1650||23||1.8 (0.6)||4.0 (0.7)|
|>1650||6||1.5 (0.5)||4.5 (0.6)|
|CLE (LD) Dose at Study Entry (mg/day)||N||Final Mean (SD) LD Dose Ratio, IPX066:CLE||Final Mean (SD) Dosing Frequency (doses/day)|
|400-550||36||2.8 (0.6)||3.4 (0.6)|
|551-750||29||2.8 (0.8)||3.6 (0.7)|
|751-950||15||2.4 (0.7)||3.3 (0.6)|
|951-1250||10||2.4 (1.0)||3.8 (0.4)|
Conclusions: For the most common LD daily doses (≤1250 mg), the ranges of final dose ratios were 2.1 to 2.4 for ADVANCE-PD and 2.4 to 2.8 for ASCEND-PD with the patients in the lowest dose ranges tending to end up at a slightly higher ratio. Mean dosing frequency was lower after conversion to IPX066. The position within each dose range had little effect on the final dose ratios.
Aspects of the abstract were submitted to American Academy of Neurology 2016 meeting.
To cite this abstract in AMA style:J. Morgan, M. Stacy, R. Rubens, S. Khanna, S. Gupta. Conversion to IPX066, extended-release carbidopa-levodopa, in advanced Parkinson’s disease patients: Dosing patterns [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/conversion-to-ipx066-extended-release-carbidopa-levodopa-in-advanced-parkinsons-disease-patients-dosing-patterns/. Accessed September 25, 2023.
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