Abstract Details

Title Long-term Evaluation of Open-label Pimavanserin Safety and Tolerability in Parkinson’s Disease Psychosis

Topic Movement Disorders

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

Poster/Presentation
Number 3-008

Objective This multi-year, open-label study assessed the long-term safety and tolerability of pimavanserin 34 mg for treating Parkinson’s disease psychosis (PDP) following participation in previous studies.

Background Pimavanserin is a selective 5-HT_2A inverse agonist/antagonist Previous results from randomized, double-blind, placebo-controlled studies showed pimavanserin to be generally safe, and well tolerated.

Design/Methods This was an 11-year open-label extension (OLE) study in patients with PDP who previously completed randomized, double-blind, placebo-controlled studies or an earlier OLE study. Study evaluations included adverse events, motor symptoms, clinical laboratory results, and other safety measures, as well as the Caregiver Burden Scale (CBS) and the Clinical Global Impressions-Severity (CGI-S) scale.

Results Among 459 participants, mean age was 71 years, 61.7% were male, and 458 (99.8%) had a previous psychiatric history. The median duration of treatment was 454.0 days (range: 1 to 3270 days). Over the entire study period, at least 1 adverse event (AE) occurred in 392 (85.4%) patients; the majority were of mild to moderate intensity, with falls (32.0%), urinary tract infection (19.0%), and hallucinations (13.7%) being most commonly reported. Serious AEs occurred in 188 (41.0%) patients, most often pneumonia, urinary tract infection, aspiration pneumonia, and hip fracture. Discontinuation for an AE occurred in 133 (29.0%) patients. 61 patients died, 59 (12.9%) during treatment or within 30 days after the last dose of study drug; the observed mortality rate was 6.45 per 100 patient-years of exposure. Serious AEs, discontinuation for AEs, and death were more common in age ≥81 years. Mean scores for the CGI-S scale and CBS remained generally stable over 192 weeks (>3.5 years) of the study period allowing for informative assessment of efficacy.

Conclusions Long-term treatment showed pimavanserin 34 mg once daily to be generally safe and well tolerated. Mortality rates suggested no increased risk following long-term treatment.

Authors/Disclosures
Clive G. Ballard, MD (The University of Exeter) PRESENTER	Clive G. Ballard, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Clive G. Ballard, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Clive G. Ballard, MD has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Clive G. Ballard, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AARP. Clive G. Ballard, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Addex. Clive G. Ballard, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novo Nordisk. Clive G. Ballard, MD has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Excivia. Clive G. Ballard, MD has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for E Lilly.
David Kreitzman, MD (Parkinsons'S Disease and Movement Disorders Center of Long Island)	Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Kreitzman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Cereval. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acadia Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Acadia Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Kreitzman has received research support from pharma 2b. Dr. Kreitzman has received research support from Neurocrine. Dr. Kreitzman has received research support from Addex. Dr. Kreitzman has received research support from Amneal.
Stuart H. Isaacson, MD, F�鶹��ýӳ�� (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.
James Norton, Jr., PhD (ACADIA Pharmaceuticals Inc.)	No disclosure on file
	No disclosure on file
	No disclosure on file
Hubert H. Fernandez, MD, F�鶹��ýӳ�� (Center for Neurological Restoration, Cleveland Clinic)	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 Amneal. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Intrance. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. 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. 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.
Tihomir V. Ilic, MD, PhD (INOVIUM NEURO)	No disclosure on file
Jean P. Azulay, MD	Dr. Azulay has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for abbvie. Dr. Azulay has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier.
Joaquim Ferreira (Instituto De Medecina Molecular Lisboa)	No disclosure on file
Victor Abler, DO (Acadia Pharmaceuticals)	Dr. Abler has stock in Acadia Pharmaceuticals .
	No disclosure on file

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