Abstract Details

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

Topic Movement Disorders

Presentation(s) P01 - (-)

Poster/Presentation
Number 065

Objective

Background IPX066 is a novel extended-release capsule oral formulation of carbidopa-levodopa (1:4 ratio), designed to provide a rapid increase in plasma concentration followed by stable concentrations allowing dosing TID in some patients. In PD patients with motor fluctuations, it has demonstrated superiority to carbidopa-levodopa immediate-release (CD-LD IR) by measures including daily off-time.

Design/Methods In two controlled IPX066 trials in advanced PD, IPX066 exposure ranged from 1 to 19 weeks. Completers of either study could enter the present study, an open-label extension lasting 9 months, commencing at their prior IPX066 level with adjustment permitted. At 1, 5, and 9 months, safety, dosing, and clinical-utility assessments were obtained; the safety assessments included adverse events (AEs), vital signs, laboratory tests, and ECGs.

Results Of 395 eligible patients, 349 (88.4%) entered the extension and 313 completed it. 88% of patients took IPX066 3 or 4 times a day, and 88% took ? 2450 mg/d. The median IPX066 daily dose at month 9 was similar to that used in the preceding trials ([sim]1450mg). During the extension, the most frequently reported AEs were dyskinesia (6.9%), fall (6.6%), pain in extremity (3.7%), hallucinations (3.4%), and arthralgia (3.2%). For these patients who entered the extension phase the most common AEs reported in the previous advanced trials were headache (6.0%), nausea (5.7%), dyskinesia (5.2%), insomnia (4.6%), and dizziness (4.3%). 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 during long-term management of advanced PD. Throughout open-label treatment, the percentage of patients reporting AEs was comparable to those in the original IPX066 trials.

Authors/Disclosures
Aaron Ellenbogen, DO PRESENTER	Dr. Ellenbogen has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for allergan. Dr. Ellenbogen has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for allergan. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ipsen. Dr. Ellenbogen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda.
Paul A. Nausieda, MD, FAAN (Wisconsin Institute for Neuro & Sleep)	No disclosure on file
	No disclosure on file
Emmanuelle Pourcher, MD (CENTRE MEDICAL JEFFERY HALE)	No disclosure on file
	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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