Question-and-Answer Session
Operator
(Operator Instructions) Your first question is from the line of Michael Lee with RBC Capital Market.
Michael Lee - RBC Capital Market
Great. Thanks Ron. Couple of quick questions, can you remind us or give us an update on what you found from the exposure response analysis on 512 and what you have determined and how you think the FDA will look at that?
Ron Barret
Sure. We have conclude as that analysis, it will be part of the NDA submission, to suddenly take a step back and explain why that is important part of any new drug application and particularly in this case, where we have mixed data on the 600 mg dose group from our Phase2 and our Phase 3 study.
With Solzira, because the act of component gabapentin is not metabolized in the body, and because the greatest contributor to the exposure that a patient exposes with a given dose is body-weight, its important to look at exposure-response as well as dose response. In this case we have done that. We have looked at a number of end-points, some of which there is not a great sensitivity in that end-point like the RLS scale, so it is difficult to discriminate between doses.
However there are some endpoints that do discriminate. There appears to be an exposure-response trend, which would suggest that on average patients are going to benefit, by having a higher dose, leading to a higher exposure.
Importantly, part of this analysis is also looking at whether there is any advantage in terms of safety and tolerability of lower exposures and lower doses. There one has to consider not only the incidence of adverse events, but the severity, the duration, whether those adverse events lead to withdraw. In the case of Solzira, the data certainly suggests that there is not a clinically meaningful difference between 600 mgs and 1200 mgs.
So this will all go into the consideration of the recommended dose. We and GSK feel confident that we have a very strong package supporting the efficacy and safety at 1200 mgs. I can not say categorically that the FDA might suggest that the label say start at 600 milligrams and proceed to 1200 milligrams. We think that it is low tolerability that the FDA would have any concern about additional studies or being required to define a safe and effective dose of Solzira.
Michael Lee - RBC Capital Market
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