Abstract Details

Title Analysis of IPX066 Dosing Data in Advanced Parkinson's Disease (PD) Patients

Topic Movement Disorders

Presentation(s) P01 - (-)

Poster/Presentation
Number 063

Objective

Background IPX066 has demonstrated clinical benefits in three Phase III trials in PD patients. It is an oral extended-release carbidopa-levodopa (CD-LD) formulation, designed to provide rapid attainment and sustained maintenance of therapeutic plasma LD concentrations. After a single dose, LD maximum concentration (Cmax) is reached at aproximately 1 hour and the concentration maintained above 50% Cmax for 4[minus]5 hours. Similar LD plasma concentration profiles have been observed across a wide range of doses in healthy volunteers and patients. IPX066 LD bioavailability (BA) and Cmax averaged [sim]70% and 30% relative to immediate-release (IR) LD.

Design/Methods Since IPX066 LD plasma concentration profile is different from IR LD products, converting patients treated with IR LD to IPX066 requires titration. In an advanced PD patient trial, initial IPX066 doses were based on baseline total daily IR LD dose, considering the reduced BA and Cmax. IPX066 was dosed approximately every 6 hours with a night-time dose allowed. Dosing more than 5 times/day was not recommended. After the initial conversion, patients were further titrated for 6 weeks. Rescue IR LD doses were not allowed.

Results In 393 patients converted from IR LD, IPX066 dose was approximately double that of IR dose. IPX066/IR LD dose ratios were slightly lower for IR LD doses ?1600 mg (Median ratio:1.57, N=10) and higher for IR LD doses <600 mg (median ratio:2.14, N=107). Most of IPX066 patients (92%) were dosed 3 or 4 times/day while 57% of IR LD patients were dosed ?5 times/day. The reduction of "off" time was not correlated with IPX066 dose or dosing frequencies.

Conclusions The LD plasma concentration profile of IPX066 allows dosing 3 or 4 times/day regardless of baseline IR LD dose or dosing frequency. IPX066 daily dose averaged twice that of IR dose.

Authors/Disclosures
Ann F. Hsu, PhD, PharmD (Lifemax Laboratories, Inc.) PRESENTER	No disclosure on file
	No disclosure on file
Sherron H. Kell, MD (Impax Laboratories, Inc.)	No disclosure on file
Suneel K. Gupta, PhD	No disclosure on file
Björn Tackenberg, MD, FAAN (F. Hoffmann-La Roche AG)	Dr. Tackenberg has received personal compensation for serving as an employee of F. Hoffmann-La Roche AG. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck Serono. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Tackenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GILEAD. Dr. Tackenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Celgene. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Tackenberg has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Tackenberg has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Tackenberg has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Merck Serono. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Tackenberg has received stock or an ownership interest from F. Hoffmann-La Roche AG. The institution of Dr. Tackenberg has received research support from Biogen. The institution of Dr. Tackenberg has received research support from Novartis. The institution of Dr. Tackenberg has received research support from Roche.

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