The Gothenburg based company has announced that an article has been published in Neurology, from the American Academy of Neurology, describing data from the company’s IPO-001 pharmacokinetic cross-over study.
In a pharmacokinetic cross-over study comprising 18 evaluable subjects with advanced Parkinson’s disease, levodopa/carbidopa solutions with a pH of 5.5 were produced by continuous buffering shortly prior to intravenous (DIZ101) or subcutaneous (DIZ102) administration. The company has reported in a press release that during the 16h of infusion, both DIZ101 and DIZ102 displayed plasma levels of levodopa comparable to those obtained by means of dose-adjusted intestinal administration of a levodopa/carbidopa gel (Duodopa, LCIG) – predefined bioequivalence aims of the study were hence met. The bioavailability of levodopa was 100% with subcutaneous administration of DIZ102 and 80% with intestinal administration of LCIG. Skin-related side effects were generally absent or mild.
“The outcome shows that subcutaneous administration of a continuously buffered levodopa solution could be a feasible technique to safely and rapidly obtain high and stable levodopa levels in patients with Parkinson’s disease,” said principal investigator Filip Bergquist, senior consultant in neurology and professor of pharmacology in the press release.
“The results suggest that DIZ102 (Infudopa SubC), administered by means of a portable twin pump, may serve as a levodopa/carbidopa monotherapy for patients requiring high levodopa levels but experience motor fluctuations when receiving oral administration.”
“The data were those that we had hoped for,” said Björn Velin, CEO of Dizlin Pharmaceuticals in the press release. “The results suggest that DIZ102 (Infudopa SubC), administered by means of a portable twin pump, may serve as a levodopa/carbidopa monotherapy for patients requiring high levodopa levels but experience motor fluctuations when receiving oral administration. The rapid uptake of levodopa from the subcutaneous tissue would enable considerable flexibility in dosing, which we also regard as an important advantage. Unlike intestinal administration of a levodopa/carbidopa gel, Infudopa SubC requires no surgery and displays considerable room temperature stability prior to mixing.”