IPX066: a novel carbidopa–levodopa extended-release formulation

Abstract

Levodopa (LD) remains the most effective medication to treat Parkinson’s disease (PD). However, most patients develop motor fluctuations and dyskinesias with long-term LD use. It is thought that these response complications are due, at least in part, to LD’s short half-life. Thus, there is great interest in long-acting LD preparations that might be able to provide robust antiparkinsonian benefit through the day and potentially avoid the development of motor fluctuations and dyskinesias. IPX066 is an investigational extended-release carbidopa–levodopa (CD–LD) formulation. It is designed to achieve rapid absorption and onset of clinical benefit, similar to CD–LD immediate release, and to provide more sustained therapeutic LD levels and longer duration of clinical benefit. In Phase III clinical trials, IPX066 was demonstrated to be efficacious in early PD compared with placebo, and in moderate-to-advanced PD, it provided more sustained clinical benefit with fewer dose administrations than CD–LD immediate release, as reported in published abstracts.

Keywords::

• carbidopa
• dyskinesia
• extended release
• fluctuations
• Impax
• IPX066
• levodopa
• medication
• Parkinson’s disease
• treatment

Financial & competing interests disclosure

RA Hauser has received consulting fees and honoraria from Impax Pharmaceuticals for work related to IPX066. In addition, he has received honoraria or payments for consulting, adivsory services, speaking services or research over the past 12 months as listed below: Advisory boards: Boehringer Ingelheim Pharmaceuticals, Inc., Teva Neuroscience, Impax Pharmaceuticals, UCB, Inc., GE Healthcare, IPSEN Pharmaceuticals, Novartis, Parkinson Study Group, Solvay, Quintiles and Biogen Idec. Speakers Bureaus: Allergan Neuroscience, GlaxoSmithKline, TEVA Neuroscience, Boehringer Ingelheim Pharmaceuticals, Inc., Novartis Pharmaceuticals and IPSEN Pharmaceuticals. Consulting: Bial, Lundbeck, Biogen Idec, Boehringer Ingelheim, Chelsea Therapeutics, GE Healthcare, Impax, Santhera Pharmaceuticals, Merck Serono/EMD Serono, Solvay Pharmaceuticals, Synosia Therapeutics, Schering–Plough, Shire Pharmaceuticals, Inc., XenoPort, Inc., Medivation, Inc. Addex, Adamas Pharmaceuticals and Noven Pharmaceuticals. Research: PICO-Tesla, Schwartz Pharma, Genzyme, Acadia, Solvay Pharmaceuticals, Impax, TEVA Neuroscience, (Merck) Serono, Schering–Plough, Novartis Pharmaceuticals, IPSEN Pharmaceuticals, XenoPort Pharmaceuticals, Chelsea Therapeutics, Allergan Neuroscience, Molecular Biometrics, The Michael J Fox Foundation for Parkinson’s Research and the National Parkinson Foundation. RA Hauser has recieved royalties from the University of South Florida. In addition, RA Hauser has consulted in litigation with lawyers representing various current and former manufacturers of welding consumables. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.