The trial on healthy volunteers involved the administration of different formulations of Chronocort followed by blood measurements of hydrocortisone taken over time. Thanks to the result of the trial, the company chose the formulation that generated a hydrocortisone profile resembling most closely that of the naturally occurring hormone for tests in a further clinical trial to demonstrate dose response.
Diurnal now hopes to move into Phase II trials this year, with an estimated completion date of mid-2013.
The European Medicines Agency (EMA) has already granted two related Orphan Drug designations to Chronocort in a move that grants ten years of market exclusivity after the product receives marketing authorisation in Europe.
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