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Abstract Details

Optimizing a Patient’s Oral CD-LD Dosing Regimen Is Critical for Improving Efficacy in Parkinson’s Disease
Movement Disorders
P4 - Poster Session 4 (11:45 AM-12:45 PM)
3-019
To provide clinical evidence of improved efficacy (“Good On” time) with optimizing immediate-release carbidopa-levodopa (IR CD-LD) or an extended-release CD-LD (IPX203) treatment.
IPX203 is an extended-release (ER), oral CD-LD formulation designed to rapidly attain therapeutic plasma LD concentrations and maintain them for 6-7 hours. IPX203 was studied in a phase 3 study (RISE-PD) that included a double-blind phase and a 9-month open-label extension.
RISE-PD was a randomized, double-blind, active-controlled phase 3 study of the safety and efficacy of IPX203 vs IR CD-LD in PD patients with motor fluctuations. All patients underwent a 3-week open-label IR CD-LD dose adjustment and a 4-week open-label conversion/optimization to IPX203, followed by randomization to a 13-week double-blind treatment with IR CD-LD or IPX203. Data from the IR CD-LD dose optimization and IPX203 dose conversion/optimization phases are important to understand potential improvement in efficacy with optimizing dosing regardless of whether the patient is on IR or ER CD-LD.
Patients entering the study had a daily “Good On” time of 9.5 hours. “Good On” time was improved to 10.3 hours at the end of the IR CD-LD dose adjustment phase and to 11.7 hours at the end of the IPX203 dose conversion/optimization phase. Patients needed on average (mean +/- SD) of 0.9 +/- 1.2 steps and 5.7 +/- 6.0 days to optimize their IR CD-LD dose. Stable dosing in the IPX203 conversion period was achieved in 1.6 +/- 1.74 titration steps and 17.2 +/- 3.7 days. A total of 630 patients entered the IR dose optimization phase and 589 entered the IPX203 dose conversion/optimization phase.
Patients experiencing motor fluctuations when taking oral CD-LD can experience improvement with dose optimization of IR CD-LD and further benefit with conversion to and optimization of IPX203.
Authors/Disclosures
Ghazal Banisadr, PhD (Amneal Pharmaceuticals)
PRESENTER 		Dr. Banisadr has received personal compensation for serving as an employee of Amneal Pharmaceuticals.
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center) Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Supernus. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoparkinson. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Intrance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NanoPharmasolutions. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll BioPharma. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Cerevance. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clario. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sumitomo. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Taurus Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sorriddi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Contera. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alterity Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Convatec Inc. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Knight Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biorasi. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medicure Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. The institution of Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stoparkinson. The institution of Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Photopharmics. The institution of Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal . Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Hauser has or had stock in Inhibikase.Dr. Hauser has or had stock in Axial Therapeutics.Dr. Hauser has or had stock in Enterin.Dr. Hauser has or had stock in Photopharmics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Inhibikase Therapeutics. The institution of Dr. Hauser has received research support from AbbVie, Inc.. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Cavion, Inc.. The institution of Dr. Hauser has received research support from Cerevance Beta, Inc.. The institution of Dr. Hauser has received research support from Cerevel Therapeutics. The institution of Dr. Hauser has received research support from Enterin, Inc.. The institution of Dr. Hauser has received research support from Genentech. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Hoffman-La Roche Inc. The institution of Dr. Hauser has received research support from Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Hauser has received research support from National Parkinson's Foundation. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from UCB BioPharma. The institution of Dr. Hauser has received research support from UCB. The institution of Dr. Hauser has received research support from Amneal Pharmaceuticals. The institution of Dr. Hauser has received research support from Motric Bio, Inc.. The institution of Dr. Hauser has received research support from Sun Pharma Advanced Research Company. The institution of Dr. Hauser has received research support from Teva Branded Pharmaceuticals. The institution of Dr. Hauser has received research support from Truebinding, Inc.. The institution of Dr. Hauser has received research support from Jazz Pharmaceuticals. The institution of Dr. Hauser has received research support from Ipsen. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Henry P. Moore, MD (University of Miami - Miller School of Medicine) Dr. Moore has received personal compensation in the range of $0-$499 for serving as a Consultant for Abbvie. Dr. Moore has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen Pharma. The institution of Dr. Moore has received research support from Sage Therapeutics. The institution of Dr. Moore has received research support from Bukwang Pharmaceutical. The institution of Dr. Moore has received research support from Neurocrine. The institution of Dr. Moore has received research support from CDHI Foundation. The institution of Dr. Moore has received research support from MODUS Outcomes LLC. The institution of Dr. Moore has received research support from University of Kansas Center for Research.
Richard D'Souza Richard DSouza has received personal compensation for serving as an employee of Amneal Pharmaceuticals. Richard DSouza has stock in Amneal Pharmaceuticals .