hrp0089lb-p8 | Late Breaking P1 | ESPE2018

Pharmacokinetics of Diazoxide Choline Controlled-Release Tablets, a Once Daily Treatment Being Evaluation in Patients with Prader Willi Syndrome

Salehi Parisa , Charlton RW , Cowen Neil

Diazoxide Choline Controlled Release Tablet (DCCR) is under development for the treatment of Prader-Willi syndrome (PWS). The objective of this research was to characterize single dose and steady state pharmacokinetics, dose linearity and food effects of DCCR across five clinical studies. Single dose pharmacokinetics of DCCR were compared to diazoxide oral suspension (Proglycem®) in a study in obese subjects (PK001). Steady state pharmacokinetics were evaluated...

hrp0089lb-p3 | Late Breaking P1 | ESPE2018

Glycemic Impact of Long Term Use of Diazoxide Choline Controlled-Release Tablets in Patients with Prader-Willi Syndrome or with Very High Triglycerides

Kimonis Virginia , Gold JA , Charlton RW , Cowen Neil , Miller JL

DCCR is a once daily tablet formulation of the choline salt of diazoxide, a KATP channel agonist. DCCR is being developed for the treatment of hyperphagia in Prader-Willi syndrome (PWS), the most common genetic cause of life-threatening obesity. In a phase 2 study, DCCR treatment resulted in significant reductions of hyperphagia and aggressive behaviors. Diazoxide increases glucose by decreasing beta-cell insulin secretion in hyperinsulinemic conditions. However, ot...