20th October 2014 - New
research
CLINICAL TRIAL RESULTS OF DUAL LAYER L-DOPA
Dual layer L-dopa (IPX066), which is being
developed for the treatment of Parkinson's Disease, unusually and advantageously
combines the immediate release version of L-dopa with the controlled release version of
L-dopa. An application by Impax is with the FDA for the marketing of IPX066 as Rytary.
For more information go to : http://www.drugs.com/nda/rytary_140411.html
Rytary
The effect of Dual Layer L-dopa on
Parkinson's Disease was compared to the effect of sinemet plus Entacapone,
which is one of the most effective forms of L-dopa.
IPX066 demonstrated improved efficacy. The
average dosage of L-dopa used in IPX066, after accounting
for availability, was 22% higher than in Sinemet and
Entacapone.
IPX066 demonstrated less "off" time
(3.8 hours instead of 5.2 hours per day). IPX066
demonstrated higher "on" time
without dyskinesia (11.4 hours instead of 10 hours per day).
Other measures favoured IPX066. There were
more adverse events when taking IPX066. The most common adverse events were dyskinesia,
insomnia, and confusional state for IPX066, and falling for Sinemet and Entacapone.
Reference : Parkinsonism Related Disorders
[2014] Aug 15 [Epub ahead of print] (F.Stocchi,
A.Hsu, S.Khanna, A.Ellenbogen, A.Mahler,
G.Liang, U.Dillmann, R.Rubens, S.Kell, S.
Gupta) Complete abstract : http://www.ncbi.nlm.nih.gov/pubmed/25306200
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