As a result of their hypotension and that inability to approve benefit on symptoms mitogen is settled with blood box has tolerability issues. The other sort of disheartening thing about this drug is that Shire really never spent the time educating the Parkinson’s Disease decisions about this drug, so there is really poor penetration into the largest market.
So we feel that neurogenic OH remains a very significant unmet medical need and again we’re really proud to be working in this area to provide Droxidopa. Now we’ve been working in the area for a while six years, we’ve learned a lot, we’ve learned that there is no successful trials in this area, whether they will be done by Shire or anyone else and some of the key challenges are listed here and anyone who has followed the story has heard a lot about these.
We’re dealing with different patient populations of underlying disease or so, heterogeneity creates issues, we’re dealing with an elderly population with potential issues of recall and being able to define their symptoms and we’re dealing with this lack of standardized studies and standardized end points.
But we’ve come a long way. We’ve had successful trials now, which I’m going to share with you, we’ve learned a lot from the fail trials and the latest issue that we are dealing with and interacting with the FDA on is the duration of these studies and the difficulty in doing long-term double-blind randomized trials. Clearly, these patients frequently dropped out for non-drug effects, they have treadmill effects where it’s hard to remember the impact of your symptoms or how you’re feeling relative to two months ago, where you were base lined and in general investigators are very reluctant to place these trial and (Inaudible) patients into long-term placebo control trials for the fear falls and the fear of all the rigors that come with the clinical trial. So when you think about long-term trials that are placebo control, do you have to think about not being able to get the most severe patients. And these are topics that we’re in process of interacting with the FDA on and having a full flow scientific dialog on.Read the rest of this transcript for free on seekingalpha.com
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