StockMarketWire.com - Pharmaceutical company Diurnal said the US Food and Drug Administration has agreed a special protocol assessment for the design, endpoints and statistical analysis approach of a pivotal study of the company's hydrocortisone drug to treat congenital adrenal hyperplasia in the US.

The assessment would provide agreement that the phase 3 trial design adequately addresses objectives that would support the regulatory submission for drug approval.

The phase 3 study of Chronocort compared with immediate-release hydrocortisone replacement therapy in participants aged 16-years and over with congenital adrenal hyperplasia is anticipated to start during H2 2021.

'Study start-up activities have already been commenced by the Company to enable a timely initiation and recruitment of up to 150 subjects with CAH who will be treated for a period of 52 weeks,' it added.




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