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Xenoport's CEO Discusses Q2 2012 Results - Earnings Call Transcript

Now turning to Arbaclofen Placarbil or AP, we expect completion of enrollment of the pivotal Phase 3 trial for the treatment of spasticity in MS patients this fall and topline results in Q1 of 2013. Patients who complete this trial are eligible to continue AP treatment in the six-month open-label safety study.

As I mentioned in our last call, we initiated communication with the FDA to discuss the possible need to modify our trials to ensure that we meet the FDA's safety data requirements of 150 subjects with six months and 100 subjects with nine months of AP exposure.

We now have FDA agreement to enroll subjects directly into the open-label safety study, allowing directly enroll subjects to stay on AP for nine months. We believe that this was a good outcome since it avoided potential modification of the Phase 3 efficacy protocol for which we have a special protocol assessment and should allow us to keep our timeline of the potential filing of the NDA in the second half of 2013.

In June, we also had a productive End-of-Phase 2 meeting with the FDA, regarding our L-Dopa prodrug 279. As I mentioned last quarter, we have discussed the data with of our Phase 2 279 trial with an advisory board comprised of Parkinson's disease experts. They indicated they believe that the pharmacokinetics of 279 compared to Sinemet were impressive, encouraged us to find a way and continue development of product candidate.

We also took note of the results of the Phase 3 trial of the intravenous infusion pump Duodopa, that were presented at AAN earlier this year, where the maximum benefit of Duodopa over optimized Sinemet was observed at 10 to 12 weeks. I’ll remind you that the length of treatment of the optimized doses of 279 and Sinemet in the randomize phase of our Phase 2 trial was only two weeks.

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