Jazz Pharmaceuticals plc and Concert Pharmaceuticals Inc announced that Phase 1 clinical data generated to date supports completing the Phase 1 evaluation of JZP-386 at the originally planned highest dose, which was not administered in the first Phase 1 trial due to a technical dosing issue. The existing Phase 1 clinical data was generated in a first-in-human trial evaluating the safety, pharmacokinetics, and pharmacodynamics of JZP-386; enrollment was completed in the third quarter. A second Phase 1 trial evaluating JZP-386 at the originally planned highest dose is expected to be initiated in the first quarter of 2015, with data expected in the second quarter of 2015.
JZP-386 is a deuterium-containing analog of sodium oxybate. The Phase 1 program is comparing JZP-386 to sodium oxybate versus placebo in healthy volunteers. The companies expect that the results from the upcoming Phase 1 trial will inform the next steps in the development program for JZP-386.
Sodium oxybate is the active ingredient in Xyrem, a prescription medicine marketed in the United States by Jazz Pharmaceuticals to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy.
