Abstract Details

Title Comparative Efficacy of Opicapone and Entacapone in the Management of Motor Fluctuations in Parkinson’s Disease

Topic Movement Disorders

Presentation(s) P3 - Poster Session 3 (5:00 PM-6:00 PM)

Poster/Presentation
Number 17-002

Objective To compare the clinical efficacy of two catechol-O-methyltransferase (COMT) inhibitors, opicapone (OPC) and entacapone (ENT).

Background OPC and ENT are used as adjunctive therapy to levodopa (LD) to improve the bioavailability of LD and reduce peak-trough fluctuations.

Design/Methods BIPARK I was a multicenter, double-blind (DB), 14- to 15-week, placebo- and active-controlled (ENT) phase 3 study, followed by a 1-year open-label extension (OLE) to evaluate the treatment effect of OPC in patients with Parkinson’s disease (PD) and motor fluctuations. A review of BIPARK I efficacy data and a sub-analysis of the OLE were conducted.

Results

BIPARK I established the noninferiority of OPC 50mg vs ENT 200mg. Moreover, it demonstrated OPC’s effectiveness in reducing “Off” time, with greater magnitude of reduction in time in “Off” state vs ENT (LS mean change of –116.8min vs –96.3min, respectively). A higher proportion of patients on OPC vs ENT showed minimally, much or very much improved Clinician (73% vs 50.9% respectively, p=0.0070) and Patient (72.1% vs 52.5% respectively, p=0.0091) Global Impression of Change scores.

At the end of the DB study, the proportion of OPC-treated patients who woke up in “On” status increased by 12.2% from baseline vs. 7.5% for ENT. For OPC -treated patients, time-to-“On” decreased by 17.7% vs 1.9% for ENT. The reduction of morning OFF-time (%/h) was two-fold greater for OPC 50mg vs ENT (20% vs 10%).

In the OLE sub-analysis, patients who switched from ENT to OPC and ended the OLE study on OPC 50mg, had significant reductions in "Off" time (LS mean change: -68.2min; p=0.0025) and significant improvements in "On" time (LS mean change: +53.3min; p=0.0195).

Conclusions Compared to ENT, OPC provides numerically higher reduction of “Off” time, increased “On” time, and a higher proportion of patients reporting meaningful clinical improvement. The benefit was maintained in the OLE study, further supporting its long-term efficacy.

Authors/Disclosures
Ghazal Banisadr, PhD (Amneal Pharmaceuticals) PRESENTER	Dr. Banisadr has received personal compensation for serving as an employee of Amneal Pharmaceuticals.
Stuart H. Isaacson, MD, FAAN (Parkinson's Dis & Mov Dis Ctr of Boca Raton)	The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for acorda. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for adamas. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuroderm. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for adamas. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Fahd Amjad, MD (Georgetown University Hospital)	Dr. Amjad has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for TEVA. Dr. Amjad has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Amjad has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Amjad has received personal compensation in the range of $0-$499 for serving as a Consultant for abbvie. Dr. Amjad has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Amjad has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Kyowna Kirin. Dr. Amjad has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Amjad has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for This information is included in the consultant disclosure. The institution of Dr. Amjad has received research support from Roche.
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.
Bruno F. Santos, MD	Dr. Santos has received personal compensation for serving as an employee of Bial.
Helena Brigas, PhD	Dr. Brigas has received personal compensation for serving as an employee of BIAL.
Bita Naderi, PharmD	Dr. Naderi has received personal compensation for serving as an employee of Amneal Pharmaceuticals . Dr. Naderi has stock in Johnson & Johnson .
Stanley Fisher, MD, FAAN	Dr. Fisher has received personal compensation for serving as an employee of Amneal Pharmaceuticals.

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