First study shows reduction in OFF time

The results of a preliminary phase II study with a new delayed release formulation of levodopa were presented at the American Academy of Neurology, which was held at Toronto in April 2010.  The study included 27 patients with Parkinson’s disease, motor fluctuations and OFF periods (when medications do not work) amounting to at least 3 hours a day.  The patients were all on stable levodopa-based therapy administered on average 5.4 times a day.  The switch to the new formulation, which required 4 administrations daily, produced a significant reduction in OFF time on average from 5.8 hours to 3.8 hours (p<0.0001) and a significant increase in ON time without disrupting involuntary movements (on average 11.9 hours vs 10.1 hours p=0.002).  Furthermore, plasma levels of levodopa were more stable with the new formulation.

The formulation is being developed by the American company Impax Pharmaceuticals , founded in 2006.  It specializes in modified release formulation of drugs for diseases of the central nervous system

Source:  Hsu et al  Acts of Toronto  Abstract no A350