The European Commission (EC) has authorised DuoCort Pharma’s Plenadren (hydrocortisone) to be marketed in the EU for the treatment of adrenal insufficiency.

The dual release hormone replacement therapy is the first pharmaceutical innovation in over 50 years for adults suffering from adrenal insufficiency, or cortisol deficiency.

Professor Gudmundur Johannsson, Chief Medical Officer at DuoCort Pharma, said: “Plenadren offers a welcome new treatment option to help patients suffering from adrenal insufficiency. It can improve therapy for many of the almost 200,000 patients in Europe who suffer from this disease and who need lifelong cortisol replacement therapy for their survival.”

The once-daily tablet is designed to imitate the normal physiological cortisol profile, with an outer layer that releases hydrocortisone immediately into the bloodstream and an inner core releasing the rest of the medicine gradually throughout the day.

Although glucocorticoid replacement therapy for adrenal insufficiency has been available for decades, complications have been linked to the medication, including premature death, impaired quality of life, increased risk of cardiovascular diseases, and decreased bone mineral density.

Adrenal insufficiency (cortisol deficiency) is a rare, life-threatening disease that affects patients in their active years. Patients require lifelong replacement therapy with hydrocortisone, the synthetic form of cortisol, replacing or substituting the hormones that the patient's adrenal glands are not producing.

DuoCort Pharma provides drug development with a focus on improving glucocorticoid therapy. The company is currently being absorbed by ViroPharma, who acquired the pharmaceutical company for an upfront payment of $33 million dollars in October.

The FDA has approved LeGoo from Pluromed, a gel that allows surgeons to temporarily stop blood flow during surgery involving blood vessels.

The temperature-sensitive gel forms a plug when injected in the bloodstream, stopping blood flow during surgery for up to 15 minutes, allowing surgeons to join blood vessels without clamps or elastic loops.

In cases where the plug needs to dissolve sooner, the surgeon can dissolve the gel plug by applying a cold pack or cold saline to the blood vessel.

The gel has been shown by clinical trials to avoid blood vessel damage and prevent blood flooding in the surgical area.

“LeGoo is an innovative device that offers surgeons an additional aid during vascular surgery,” said Christy Foreman, Director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The gel’s unique properties may facilitate surgeries that entail the joining or grafting blood vessels.”

The FDA based the approval on studies showing that LeGoo is both biocompatible and non-toxic. Clinical trials involving 110 patients undergoing bypass surgery without stopping the heart proved that LeGoo was as safe and effective as vessel loops, commonly used to stop blood flow during coronary bypass surgery.

Based in Massachussetts, USA, Pluromed specialises in injectable plugs to control bleeding during surgery, based on its proprietary polymer technology.