Abstract Details

Title Long-term Safety and Efficacy of IPX203 in Parkinson’s Disease Patients with Motor Fluctuations: A 9-Month Open-label Extension Trial

Presentations S32 - Movement Disorders: Trials

Background

IPX203 is an investigational oral extended-release (ER) carbidopa-levodopa (CD-LD) that contains immediate-release (IR) granules, ER beads, and mucoadhesive polymers to prolong therapeutic LD plasma concentrations. In a Phase 3 study, IPX203 was shown to be superior to IR CD-LD for “Good On” time.

Objective

To assess the long-term safety and efficacy of IPX203.

Design/Methods

This was a 9-month, multicenter, open-label safety extension study. Parkinson’s patients with motor fluctuations who had successfully completed the Phase 3 double-blind study comparing the safety and efficacy of IPX203 with IR CD-LD were invited to enroll in this study.

Results

Between April 3, 2019, and March 21, 2022, 419 patients were enrolled and received treatment; 352 (84%) patients completed the study; 67 (16%) discontinued. The primary reasons for discontinuation were patient withdrawal (22 [32.8%]), adverse events (AEs) (20 [29.9%]), and lack of efficacy (14 [20.9%)]. IPX203 was generally safe and well tolerated. Overall, 221 (52.7%) patients experienced treatment-emergent AEs (TEAEs). The most frequent TEAEs (≥2% patients) were dyskinesia (21 [5.0%]), fall (21 [5.0%]), urinary tract infection (21 [5.0%]), back pain (15 [3.6%]), constipation (11 [2.6%]), and COVID-19 (10 [2.4%]). The majority of TEAEs were mild or moderate in severity and occurred within the first 90 days of treatment. All efficacy measures were stable throughout the study period of 9 months. Most patients reached a stable dosing regimen by 3 months of treatment; the average daily dosing frequency of IPX203 was generally stable over the 9-month period. The average (mean [SD]) daily dosing frequency of IPX203 was 3.1 (0.45) times/day, the mean±SD daily dose of IPX203 was 1539.61±630.837 (range: 420.0, 4458.9) mg and the median (range) treatment duration was 271.0 (16, 369) days.

Conclusions

In this 9-month open-label extension study, IPX203 exhibited a favorable safety and tolerability profile, and efficacy was maintained from baseline to the end of the study.

Authors/Disclosures
Alberto J. Espay, MD, FAAN (University of Cincinnati) PRESENTER	Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuroderm. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acorda. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Herantis Pharma. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus (formerly USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AskBio. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Supernus (formerly, USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Avion Pharmaceuticals. The institution of Dr. Espay has received research support from NIH. The institution of Dr. Espay has received research support from Michael J Fox Foundation for Parkinson's Research. Dr. Espay has received intellectual property interests from a discovery or technology relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care.
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 Acadia Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Adamas Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aptinyx. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Britannia. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for CAVR. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ClearView Healthcare Partners. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Decision Resource Group (DRG). Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Enterin. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FirstWord. 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 $500-$4,999 for serving as a Consultant for GuidePoint Global. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Huron. Dr. Hauser has received personal compensation in the range of $0-$499 for serving as a Consultant for InSearch Consulting. Dr. Hauser has received personal compensation in the range of $0-$499 for serving as a Consultant for Insignia Strategies. 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 $500-$4,999 for serving as a Consultant for KeiferRX LLC. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for KeyQuest. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for KX Advisors. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Kyowa Kirin Pharmaceuticals. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for L.E.K. Consulting. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck A/S. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 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 NOVUS. Dr. Hauser has received personal compensation in the range of $0-$499 for serving as a Consultant for Perception OpCo (Cerevel Therapeutics LLC). Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ROCHE . 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 $10,000-$49,999 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 $500-$4,999 for serving as a Consultant for US World Meds. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pharmather. Dr. Hauser has received personal compensation in the range of $0-$499 for serving as a Consultant for Global Life Sciences. Dr. Hauser has received personal compensation in the range of $500-$4,999 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 $500-$4,999 for serving as a Consultant for LifeSciences Consultants. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Research Catalyst . Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Curium Pharma. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Syneos. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Hauser has received personal compensation in the range of $500-$4,999 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 Pharma 2 B. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vivifi Biotech. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sio Gene Therapies. Dr. Hauser has received personal compensation in the range of $500-$4,999 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 Alterity. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ameal. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Projects in Knowledge. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for DDB Health. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BRACKET/Signant. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Efficient CME. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Kansas City Southwest Clinical Society. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Triangle Insights. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clarity Science, LLC. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BioMedical Insights. Dr. Hauser has received personal compensation in the range of $0-$499 for serving as a Consultant for Coleman Research. Dr. Hauser has received personal compensation in the range of $0-$499 for serving as a Consultant for Deallus. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EPI-Q. 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 $500-$4,999 for serving as a Consultant for Health Advances. 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 $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 $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Vivifi Biotech. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ADAMAS . Dr. Hauser has received personal compensation in the range of $500-$4,999 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 Amneal. 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 $500-$4,999 for serving on a Speakers Bureau for Neurochallenge. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kansas City Southwest Clinical Society. Dr. Hauser has stock in Inhibikase. Dr. Hauser has stock in Axial Therapeutics. The institution of Dr. Hauser has received research support from Biogen, Inc.. The institution of Dr. Hauser has received research support from Cavion, Inc. The institution of Dr. Hauser has received research support from Centogene. The institution of Dr. Hauser has received research support from Cerevel. The institution of Dr. Hauser has received research support from Cynapsus Therapeutics. The institution of Dr. Hauser has received research support from Enterin. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Impax Laboratory. The institution of Dr. Hauser has received research support from Intec Pharma. The institution of Dr. Hauser has received research support from Jazz Pharmaceuticals, Inc.. The institution of Dr. Hauser has received research support from Neuro Derm. The institution of Dr. Hauser has received research support from Northwestern University. The institution of Dr. Hauser has received research support from Pfizer. The institution of Dr. Hauser has received research support from Pharma 2 B. The institution of Dr. Hauser has received research support from Revance Therapeutics. The institution of Dr. Hauser has received research support from Roche. The institution of Dr. Hauser has received research support from Sun Pharma Advanced Research. The institution of Dr. Hauser has received research support from Sunovion. The institution of Dr. Hauser has received research support from AbbVie. The institution of Dr. Hauser has received research support from Axovant Sciences Ltd.. The institution of Dr. Hauser has received research support from Cerevance. The institution of Dr. Hauser has received research support from MJFF. The institution of Dr. Hauser has received research support from Neuraly. The institution of Dr. Hauser has received research support from Sanofi US Services, Inc.. The institution of Dr. Hauser has received research support from Bukwang Pharmaceuticals. The institution of Dr. Hauser has received research support from Integrative Research Laboratories Sweden AB. The institution of Dr. Hauser has received research support from Genentech, Inc.. The institution of Dr. Hauser has received research support from UCB Biopharma SPRL. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.
Stanley Fisher, MD, FAAN	Dr. Fisher has received personal compensation for serving as an employee of Amneal Pharmaceuticals.
Leslie Cloud, MD (VCU)	The institution of Dr. Cloud has received research support from NIH. Dr. Cloud has received personal compensation in the range of $500-$4,999 for serving as a Community leader with Paltown.
Rohit Dhall, MD (University of Arkansas for Medical Sciences)	Dr. Dhall has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Cala Health. Dr. Dhall has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Best Doctors Inc. Dr. Dhall has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pharma2B. Dr. Dhall has stock in Atea Pharmaceuticals. Dr. Dhall has stock in Armata Pharmaceuticals. Dr. Dhall has stock in Gilead Health Science. Dr. Dhall has stock in Compass Pathway. Dr. Dhall has stock in Imara Pharmaceuticals. The institution of Dr. Dhall has received research support from Amneal. The institution of Dr. Dhall has received research support from Neuroderm. The institution of Dr. Dhall has received research support from Cerevel Therapeutics. The institution of Dr. Dhall has received research support from Neurocrine. The institution of Dr. Dhall has received research support from Neuraly. The institution of Dr. Dhall has received research support from SPARC. The institution of Dr. Dhall has received research support from Pharma2B. The institution of Dr. Dhall has received research support from Alexion. The institution of Dr. Dhall has received research support from Parkinsons Foundation.
Sandeep Thakkar, DO	Dr. Thakkar has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for abbvie. Dr. Thakkar has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for abbvie. Dr. Thakkar has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for neurocrine. Dr. Thakkar has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for teva. Dr. Thakkar has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for medtronic.
Ghazal Banisadr, PhD (IMPAX LABORATORIES)	Dr. Banisadr has nothing to disclose.
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.