Cardiff, UK – Diurnal Limited today announced that it has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for its cortisol replacement product Chronocort®, an oral capsule drug candidate for the treatment of Congenital Adrenal Hyperplasia. The designation affords seven years of exclusivity in the US following market authorisation and follows the orphan drug designation already granted in Europe by the European Medicines Agency for Chronocort®.
Chronocort® is a modified-release hydrocortisone preparation specifically designed to provide cortisol replacement throughout the day in a manner that mimics, as closely as possible, the natural circadian rhythm (the body’s natural 24 hour hormone cycle) of cortisol. Diurnal has recently successfully completed a Phase 2 human volunteer study of Chronocort® at the National Institutes of Health Clinical Center, Bethesda, Maryland, which demonstrated the appropriate release profile of hydrocortisone and consequent control of androgens. Planning is now underway for a large multi-center clinical trial Phase 3 to start in 2015 - the next pivotal phase of the study of Chronocort® therapy.
About Diurnal Limited
Founded in 2004, Diurnal is a UK-based specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including Congenital Adrenal Hyperplasia. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.
Martin Whitaker, Chief Executive Officer at Diurnal Ltd, commented:
“This orphan drug designation is an important regulatory advancement for Diurnal and supports our global development strategy for Chronocort® to achieve our goal of providing improved therapies for patients with Congenital Adrenal Hyperplasia, a disease with limited treatment options”
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