Better quality of life with new orphan drug for Addison´s disease
- Details
- Published on Monday, 21 June 2010 00:00
Helsingborg / San Diego - DuoCort Pharma´s new physiological treatment for adrenal insufficiency improves patients' quality of life. The Swedish pharmaceutical company presents new data from its phase II/III trial at the 92nd annual ENDO congress in San Diego today.
The new treatment from DuoCort Pharma has a more physiological release profile which mimics the
natural secretion pattern of cortisol. In this way, treatment outcome and
quality of life are improved for patients. The company has also developed
methods to optimize the dosage regimen which also contributes to an improvement
in therapy over time.
DuoCort Pharma is
also presenting the results of a worldwide survey of 1200 adrenal insufficiency patients. Over 60% report that current therapy results in reduced
and compromised quality of life necessitating changes to physical activity,
social life, work life and family life. Three quarters are concerned about long term
side effects of their replacement therapy such as osteoporosis, obesity,
fatigue and cardiovascular morbidity, in that order. These data demonstrate a large need for
improvement in glucocorticoid replacement therapy.
These results confirm
several earlier studies showing premature death, compromised quality of life, and
increased cardiovascular risk factors in patients treated for adrenal
insufficiency. The likely reason for these outcomes is the very outdated
replacement treatment that is used today which cannot mimic the normal diurnal cortisol profile.
Gudmundur Johannsson, professor and senior
physician at the
Department of Endocrinology, Sahlgrenska
University Hospital, Gothenburg, Sweden and Chief Medical Officer of
DuoCort Pharma, says "This new more physiological
therapy has excellent potential to significantly improve cortisol replacement for over 200 000 patients in Europe and
more than 125 000 patients in the US who suffer from adrenal insufficiency
and need life-long cortisol replacement therapy for survival. The
improvement in cardiovascular risk factors, well-being and quality of life as well
as a simplified and more individualised dosage regimen will make this a welcome
new treatment option to help patients lead a more normal life."
Earlier this
year a market authorisation application was filed with the European Medicines
Agency, which is an important step towards market introduction for the new
orphan drug from DuoCort Pharma.
About Adrenal insufficiency
Patients suffering from adrenal insufficiency
(cortisol deficiency) are unable to produce their own cortisol.
To survive, they need replacement therapy with hydrocortisone.
Adrenal insufficiency is a rare disease that affects
patients in their active years. Because
it is a chronic condition, they require this life-saving therapy throughout
their lives. Treatment of adrenal insufficiency involves replacing, or substituting,
the hormones that the patient´s own adrenal glands are not making. Cortisol is
replaced using hydrocortisone,
the synthetic form of cortisol.
There are different types of adrenal
insufficiency: primary
adrenal insufficiency also called Addison´s disease,
secondary adrenal insufficiency and CAH - congenital adrenal hyperplasia.
For
more details on the data please also see:
http://www.abstracts2view.com/endo/view.php?nu=ENDO10L_P3-646
http://www.abstracts2view.com/endo/view.php?nu=ENDO10L_P2-677
http://www.abstracts2view.com/endo/view.php?nu=ENDO10L_P3-644
DuoCort Pharma AB is a project company of the
life science incubator PULS.
For more information visit www.pulsinvest.se.
Contact Information
Gudmundur Johannsson, Chief Medical
Officer, tel +46 70-528 08 72
Maria Forss, CEO tel +46 70-967 00 07
Jacob Kaluski, Chairman of
the Board of Directors, tel +46 70-356
56 65
Please find the press release as pdf here: 