XENOPORT ANNOUNCES RESULTS FROM PHASE I TRIAL

XenoPort announced the successful completion of an initial Phase I clinical trial of XP19986, a transported prodrug of R-baclofen. The objective of the trial was to assess safety, tolerability and pharmacokinetics of three different formulations of XP19986 in healthy adult volunteers. One of the formulations was an immediate-release formulation, while the other two formulations were intended to release XP19986 is a more sustained fashion.

The Phase I trial was conducted in two stages. The first stage was a double-blind, placebo-controlled, single-dose, dose-escalation trial of the IR formulation tested in separate cohorts of ten fasted subjects.

The second stage of the Phase I trial was a double-blind, placebo-controlled, single-dose, randomized, cross-over trial of the IR and two different SR formulations (8 mg of XP19986 in each case) tested in separate cohorts of ten subjects. In the second stage of the trial, each formulation was administered to the same subjects with and without food with one week between dosing. Subjects were monitored for adverse events, and blood and urine were sampled to deter mine pharmacokinetic profiles and bioavailability.