New Extended-Release Levodopa Reduces Off Time versus IR Levodopa (AAN 2010)

Subject: New Extended-Release Levodopa Reduces Off Time versus IR Levodopa (AAN 2010)

Date: 5/24/2010

E-MOVE reports from the 62nd Annual Meeting of the American Academy of Neurology, held in Toronto April 10-17, 2010. Abstract and page numbers are from Neurology 2010;74 (suppl 2)

A new extended-release formulation of levodopa-carbidopa improves off time without significantly increasing troublesome dyskinesias, according to a new study. The drug, IPX066, is manufactured by Impax Pharmaceuticals, which sponsored the study.

Twenty-seven PD patients with at least 3 hours of daily off time received either immediate-release levodopa at their pre-study dosing schedule (average 5.4 doses per day), or IPX066 every 6 hours, for one week, followed by one week of their pre-study treatment schedule, followed by cross-over to the other arm. Other anti-PD medications were continued during the study, with the exception of COMT inhibitors.

Results showed:

--IPX066 produced more stable steady-state plasma levodopa concentrations versus IR levodopa

--Off time decreased by 2 hours (p<0.0001), and on time by almost 2 hours (p=0.002), in patients taking IPX066, versus negligible changes in patients on IR levodopa.

--Total times in each state:

 
	IPX066	IR levodopa	p 
off time (hours)	3.83	5.83	<0.0001 
on time w/no or non- 
troubling dyskinesias	11.88	10.07	0.002 
on time w/troubling 
 dyskinesias	1.25	0.9	0.389

--Time to best on state, as determined by finger-tapping speed, did not differ between treatments.

“IPX066 may provide important clinical benefit and offer a significant treatment option in the management of motor complications in PD,” the authors conclude.

Comparison of IPX066, a novel extended-release oral carbidopa-levodopa formulation, to immediate-release carbidopa-levodopa in patients with advanced Parkinson’s disease
A Hsu, L Verhagen Metman, A Ellenbogen, M O’Connell, NB Modi, S Kell, S Gupta
P04.129, A350