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Abstract Details

Integrated safety summary from Phase 3 clinical trials of IPX203, an extended-release carbidopa-levodopa formulation, in Parkinson disease
Movement Disorders
P1 - Poster Session 1 (8:00 AM-9:00 AM)
5-006

IPX203 is an investigational oral extended-release carbidopa-levodopa (CD-LD) designed to produce prolonged therapeutic LD plasma concentrations. IPX203 has shown improvement in “Good On” time compared to immediate-release CD-LD.

To present the adverse event (AE) profile of IPX203 in the Phase 3 clinical trials in Parkinson disease (PD).

Safety data from a multi-center, double-blind, randomized, active-controlled Phase 3 study and an open-label extension Phase 3 study were combined and analyzed.

Safety population consisted of 630 patients with PD experiencing motor fluctuations, with a mean age of 66.5yrs (9.0), and mean duration of disease of 8.5yrs (4.9). The average total daily dose (TDD) of IPX203 was 1520.97 mg (±587.78); most subjects (83.0%) received IPX203 at an average TDD between 800 mg and <2400 mg of LD. The average daily dosing frequency of IPX203 was 3.08 times/day, the mean (range) treatment duration was 242.9 (2 to 553) days and person-years of exposure was 388.34. The majority, 385/584 (65.9%), were exposed to IPX203 for 6 months or longer, and 179 (30.7%) were exposed for 12 months or longer.

In the Phase 3 studies pool, 397 (67.4%) of IPX203 subjects experienced 1355 treatment-emergent AEs (TEAEs) (837 mild, 419 moderate, 99 severe). Of these, 205 (34.8%) experienced 471 TEAEs that were treatment-related. The most reported TEAEs were dyskinesia (10.7%), nausea (7.5%), fall (5.9%), and urinary tract infection (5.3%). The analysis of TEAEs by duration of exposure to study treatment showed that most IPX203 subjects (55.0%) experienced TEAEs (first onset) within the first 3 months. The occurrence of TEAEs remained stable over time.

Considering the disease duration and presence of motor fluctuations in the PD cohort enrolled in our Phase 3 trials, IPX203 was generally safe and well tolerated; the safety profile was stable over time and consistent with the known effects of other LD formulations.

Authors/Disclosures
Hubert H. Fernandez, MD, FAAN (Center for Neurological Restoration, Cleveland Clinic)
PRESENTER
Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Fernandez has received research support from Biogen. The institution of Dr. Fernandez has received research support from Michael J Fox Founda. The institution of Dr. Fernandez has received research support from Roche. The institution of Dr. Fernandez has received research support from Parkinson Foundation. The institution of Dr. Fernandez has received research support from UCB. Dr. Fernandez has received publishing royalties from a publication relating to health care. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as a Steering Committee/Advisory Committee Member with Parkinson Study Group.
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center) Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Global Kinetics Consulting (GKC). Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Jazz Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroDerm. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scion Neurostim LLC. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tolmar Inc.. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus Pharma. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Inhibikase. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pharma 2 B. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vivifi Biotech. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage Therapeutics. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Orion. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ovid Therapeutics. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AgeX Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avanex. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MDCE Suzhou. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedRhythms. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PDNeurotechnology. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Regenxbio. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Tremor Research Support Group. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tris Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. 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. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda Therapeutics. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Ameal . Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Sunovion. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Cerevel. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Inhibikase. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has stock in Inhibikase. Dr. Hauser has stock in Axial Therapeutics. Dr. Hauser has stock in Enterin. Dr. Hauser has stock in Revance Therapeutics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Artizan Biosciences. The institution of Dr. Hauser has received research support from Parkinsons & Movement Disorder Alliance. 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 Aeon Biopharma. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Bukwang Pharmaceutical Co., Ltd.. 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 Cynapsus 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 Impax Labratories. The institution of Dr. Hauser has received research support from Integrative Research Labratories Sweden. The institution of Dr. Hauser has received research support from Lundbeck, 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 Neuraly Inc.. The institution of Dr. Hauser has received research support from Neurocrine Biosciences. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Pharma Two B Ltd.. The institution of Dr. Hauser has received research support from Revance Therapeutics. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Sanofi Pharmaceuticals. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from SunPharma. The institution of Dr. Hauser has received research support from UCB BioPharma. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Vanessa K. Hinson, MD, PhD, FAAN (MUSC) The institution of Dr. Hinson has received research support from Biogen. The institution of Dr. Hinson has received research support from Scion Neurostim. The institution of Dr. Hinson has received research support from PPD Development/Takeda Development. The institution of Dr. Hinson has received research support from Parexel Biopharma. The institution of Dr. Hinson has received research support from Impax Laboratories.
Nirav Pavasia, MD (Neurology Consultants of Dallas) Dr. Pavasia has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Pavasia has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Pavasia has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Pavasia has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Supernus. Dr. Pavasia has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Eric Molho, MD, FAAN (Parkinson's Disease & Movement Dis Ctr) Dr. Molho has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Molho has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for CNS Ratings. Dr. Molho has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine Biosciences.
Leonid Zeitlin, PhD (Veranex Solutions) The institution of Dr. Zeitlin has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Veranex Solutions.
Hester Visser Hester Visser has received personal compensation for serving as an employee of Amneal Pharmaceuticals LLC. Hester Visser has received stock or an ownership interest from Amneal Pharmaceuticals LLC.
Richard D'Souza No disclosure on file