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 | | DUOCORT GETS ORPHAN DRUG DESIGNATION IN THE US FOR TREATMENT OF ADRENAL INSUFFICIENCY | | | DuoCort AB | | 27/06/2008 | | | DuoCort Pharma AB, a privately held Swedish drug development company, today announced that the US Food and Drug Administration (FDA) has granted an Orphan Drug Designation for the company’s DuoCort™ hydrocortisone dual-release oral tablet in development for the treatment of adrenal insufficiency – the inability of the body to produce sufficient amounts of the essential hormone cortisol. Orphan drug designation will give DuoCort™ market exclusivity in the US for seven years after the product attains marketing authorization.
"Current research confirms that conventional therapy is suboptimal and is not serving patients as well as it should. There is scope for improvement in the delivery of cortisol replacement and we are convinced DuoCort™ will offer a better treatment option for patients with adrenal insufficiency and deliver better long-term outcomes,” said Dr. Gudmundur Johannsson, Chief Medical Officer of DuoCort Pharma.
“Orphan designation in the US will facilitate this development aimed at demonstrating the significant benefit of cortisol replacement which effectively mimics the physiological diurnal release profile of cortisol in a convenient once-daily tablet. The new DuoCort™ therapy will be the first real innovation for adrenal insufficiency patients in over 30 years,” continued Dr. Johannsson.
The orphan-designated product is a novel, dual-release, oral hydrocortisone tablet in 5 mg and 20 mg dosage strengths currently in late stage clinical trials in Europe. DuoCort™ will improve today’s cortisol replacement therapy with a once-daily tablet that delivers a more physiological dose of the active substance, better mimicking the body’s own cortisol serum profile.
DuoCort™ 5 mg and 20 mg dual-release hydrocortisone tablets are currently undergoing a pivotal clinical Phase II/III trial in Europe assessing the pharmacokinetics, safety and tolerability of once-daily DuoCort™ in comparison to conventional thrice-daily oral hydrocortisone therapy in patients with adrenal insufficiency. The trial commenced in August 2007 and is being conducted at five University endocrinology clinics. Data from the study is expected to be available in the second half of 2008. With normal regulatory review and approval times, DuoCort™ could be on the market by 2010.
Orphan Drug legislation in the US provides incentives to encourage the development and marketing of medicines for rare diseases. Designation as an orphan medicinal product does not indicate that the product has yet fulfilled the efficacy, safety and quality criteria required for drug marketing. These remain to be fulfilled in the pharmaceutical and clinical development of the drug and assessed by the FDA at the marketing authorisation stage. | |
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