Abstract Details

Title Motor Responses to Apomorphine Sublingual Film Compared With Levodopa in Patients With Parkinson’s Disease and “OFF” Episodes

Topic Movement Disorders

Presentation(s) P9 - Poster Session 9 (12:00 PM-1:00 PM)

Poster/Presentation
Number 3-001

Objective To compare time to onset, duration, and magnitude of motor improvement following administration of apomorphine sublingual film (APL-130277; APL) versus levodopa in patients with Parkinson’s disease (PD) and “OFF” episodes.

Background Previous studies have shown that onset of motor improvement occurred faster with subcutaneous apomorphine compared with levodopa, with a similar magnitude of response.

Design/Methods Adult patients with PD and “OFF” episodes receiving levodopa were enrolled. At screening, patients in an “OFF” state were observed for a FULL “ON” response following their usual morning levodopa dose. During open-label titration, patients received increasing doses of APL (10–35 mg) until a FULL “ON” response was achieved without intolerable side effects. Motor responses following open-label APL and levodopa administration were compared descriptively using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score, assessed predose and at 15, 30, 45, 60, and 90 minutes postdose.

Results One-hundred nine patients treated with APL and levodopa were evaluated (levodopa data were missing for 1 patient). Predose MDS-UPDRS Part III scores were comparable (43.5 vs 43.1). At 15 minutes postdose, the magnitude of motor response with APL was ~2-fold higher than with levodopa (–12.6 vs –6.0, respectively). Peak response to APL occurred earlier (45 minutes) than with levodopa (90 minutes) across the timepoints measured, and the magnitude of peak responses was comparable (–26.1 vs –27.9, respectively). Notably, APL was still associated with a clinically meaningful improvement at 90 minutes postdose (–19.9).

Conclusions APL was associated with an earlier onset of motor improvement and earlier peak response versus levodopa in patients with PD and “OFF” episodes. APL continued to provide a clinically meaningful improvement at 90 minutes postdose, suggesting that it may offer a durable on-demand treatment for “OFF” episodes. Additional studies are warranted to validate the findings from this open-label, post hoc analysis.

Authors/Disclosures
Jennifer S. Hui, MD (University of Southern California) PRESENTER	Dr. Hui has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sunovion. Dr. Hui has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion. The institution of Dr. Hui has received research support from Roche. The institution of Dr. Hui has received research support from Abbvie. Dr. Hui has received personal compensation in the range of $500-$4,999 for serving as a Roundtable speaker with Medscape .
Susan Fox, MD, F�鶹��ýӳ�� (Toronto Western Hospital)	The institution of Dr. Fox has received research support from MJFF/Safra. The institution of Dr. Fox has received research support from Parkinson Canada. The institution of Dr. Fox has received research support from NIH. Dr. Fox has received publishing royalties from a publication relating to health care.
	No disclosure on file
	No disclosure on file
Eric J. Pappert, MD (Neurology Associates)	No disclosure on file
	No disclosure on file
Bradford A. Navia, MD, PhD (Aprinoia Therapeutics)	No disclosure on file

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