DuoCort Gets Orphan Drug Status
The FDA has granted orphan drug status to DuoCort, a hydrocortisone dual-release oral tablet, which is being developed by the Swedish company DuoCort Pharma to treat adrenal insufficiency.
Adrenal insufficiency robs people of the ability to produce enough of the essential hormone cortisol. Orphan drug designation gives DuoCort market exclusivity in the U.S. for seven years after it receives marketing authorization.
Studies show that conventional therapy “is not serving patients as well as it should,” Gudmundur Johannsson, chief medical officer of DuoCort Pharma, said. The drug’s cortisol replacement action mimics the body’s daily release of cortisol and is “the first real innovation for adrenal insufficiency patients in over 30 years,” he added.
DuoCort is being tested in Phase II/III clinical trials in Europe in 5-mg and 20-mg doses in comparison with conventional thrice-daily oral hydrocortisone therapy. The trial began last August and is being conducted in five university endocrinology clinics with data expected this year. With normal regulatory review and approval times, DuoCort could be on the market by 2010, the company said.