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Abstract Details

Improvement in Uninterrupted Good ON Time and Reduction in OFF Periods with CSAI Treatment
Movement Disorders
P11 - Poster Session 11 (8:00 AM-9:00 AM)
5-028

Evaluate the effect of continuous subcutaneous apomorphine infusion (CSAI) on daily OFF time and Good ON time (ON without troublesome dyskinesia) via diaries in people with Parkinson disease (PD) and motor fluctuations.

The Phase 3 open-label InfusON study (NCT02339064) showed that, after 12 weeks of maintenance treatment with CSAI, patients’ daily OFF time decreased by a mean of -3.0 hours with a corresponding increase in Good ON time (+3.1 hours).

InfusON enrolled individuals experiencing ≥3 hours of daily OFF time despite optimized therapy. Patients were titrated to optimal CSAI rates before entering a 52-week Maintenance Period. OFF time was measured at Week 12 using Hauser PD diaries. In this post hoc analysis, patient data were analyzed via heat maps showing periods of sleep, OFF time, Good ON time, and ON time with troublesome dyskinesia at 30-minute intervals. The longest period of uninterrupted Good ON time was also determined.

Of 99 enrolled patients, 65 had evaluable diaries at Baseline and Week 12. The infusion rate at Week 12 was median (range) 4 (1,7) mg/h. Waking-hour diary entries showed reduced OFF time for most patients (mean ± SD: -3.1 ± 3.16 h from Baseline: 6.6 ± 2.43), with some patients reporting no waking hour OFF time. The percent change from Baseline in the number of OFF periods was -40 ± 35.4%. The mean daily longest duration of uninterrupted Good ON time increased from 4.4 ± 2.73 h at Baseline to 9.6 ± 5.80 h at Week 12. Despite dyskinesia being commonly reported during titration, heat maps showed fewer patients reporting troublesome dyskinesia at Week 12 (n=6) than at Baseline (n=12).

CSAI therapy reduced patients’ daily number of OFF periods, reduced overall OFF time, and on average more than doubled longest duration uninterrupted Good ON time.

Authors/Disclosures
Daniel Kremens, MD, JD, FAAN (Sidney Kimmel Medical College At Thomas Jefferson University)
PRESENTER
Dr. Kremens has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Supernus. Dr. Kremens has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Neurocrine. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Kremens has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Teva. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Kremens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Cerevel. Dr. Kremens has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for UCB.
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.
Andrea Formella, PharmD, BCPP (Supernus Pharmaceuticals) Dr. Formella has received personal compensation for serving as an employee of Supernus Pharmaceuticals, Inc. Dr. Formella has stock in Supernus Pharmaceuticals, Inc..
Milan Joshi Mr. Joshi has received personal compensation for serving as an employee of Supernus Pharmaceuticals, Inc..
Mindy Grall, PhD, NP Ms. Grall has received personal compensation for serving as an employee of Supernus Pharmaceuticals. Ms. Grall has or had stock in Supernus.