Abstract Details

Title Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in Patients with Early Parkinson's Disease

Topic Movement Disorders

Presentation(s) P01 - (-)

Poster/Presentation
Number 064

Objective

Background IPX066 is a novel, oral, extended-release capsule formulation of carbidopa-levodopa (1:4 ratio), designed to provide a rapid increase in plasma concentration followed by stable concentrations allowing dosing TID. In early PD, it demonstrated statistically significant benefit compared to placebo by multiple measures including UPDRS Parts II+III.

Design/Methods For a Phase-3 study of three fixed IPX066 dosage levels (145mg, 245mg, and 390mg) TID versus placebo, early PD patients not taking dopamine agonists or COMT inhibitors underwent study-drug escalation followed by maintenance (treatment total, 30 weeks). Completers were eligible for the present study, an open-label extension lasting 9 months. At entry, IPX066 was up-titrated as if all patients were levodopa-naive, to achieve individualized regimens. Safety, dosing, and clinical-utility assessments were performed at 1, 5, and 9 months, including adverse events (AEs), vital signs, laboratory tests, and ECGs.

Results Of 300 eligible patients, 268 (89.3%) entered the extension and 254 completed it. The final median daily frequency of IPX066 was three times a day. The median total daily dose was 720mg. During the extension, the most frequently reported AEs were nausea (5.6%), insomnia (5.6%), hypertension (4.1%), and headache (3.7%). For patients who entered the extension phase the most common AEs reported in the antecedent trial were nausea (13.4%), headache (13.1%), dizziness (11.2%), and insomnia (4.9%). Of interest, the dyskinesia of 1.9% reported in the extension was similar to the 2.6% in the previous blinded trial. Throughout the extension, IPX066 maintained efficacy (on UPDRS Parts II+III), and non-AE safety assessments showed no clinically significant trends.

Conclusions Overall, IPX066 demonstrated a favorable tolerability profile throughout extended dosing in early PD. During open-label administration, the frequency of AEs reported was typical of this population.

Authors/Disclosures
Paul A. Nausieda, MD, FAAN (Wisconsin Institute for Neuro & Sleep) PRESENTER	No disclosure on file
Gereon Nelles, MD, PhD, FAAN (Neurologische Praxis)	Dr. Nelles has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Industry. Dr. Nelles has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Industry. Dr. Nelles has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Industry. Dr. Nelles has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Industry. Dr. Nelles has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Industry. Dr. Nelles has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Industry. Dr. Nelles has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Industry. Dr. Nelles has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Dr. Nelles has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Memodio. Dr. Nelles has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Industrial. Dr. Nelles has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Industry. Dr. Nelles has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Industry. Dr. Nelles has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Industry. Dr. Nelles has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Industry. Dr. Nelles has received personal compensation in the range of $5,000-$9,999 for serving as an officer or member of the Board of Directors for German Neurologists Professional Organization. Dr. Nelles has received publishing royalties from a publication relating to health care.
	No disclosure on file
Sherron H. Kell, MD (Impax Laboratories, Inc.)	No disclosure on file
	No disclosure on file
Ann F. Hsu, PhD, PharmD (Lifemax Laboratories, Inc.)	No disclosure on file
Suneel K. Gupta, PhD	No disclosure on file

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