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Research and News

Questions About Korlym?

Feb 27 2012 10:38 PM | MaryO in Research and News

Have questions about the new Korlym? How about Korlym vs ketoconazole? About medical vs surgical treatment for Cushing's.
Ask Dr. Theodore Friedman.

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Theodore C. Friedman, M.D., Ph.D. has opened a private practice, specializing in treating patients with adrenal, pituitary, thyroid and fatigue disorders. Dr. Friedman has privileges at Cedars-Sinai Medical Center and Martin Luther King Medical Center. His practice includes detecting and treating hormone imbalances, including hormone replacement therapy. Dr. Friedman is also an expert in diagnosing and treating pituitary disorders, including Cushings disease and syndrome.
Dr. Friedman's career reflects his ongoing quest to better understand and treat endocrine problems. With both medical and research doctoral degrees, he has conducted studies and cared for patients at some of the country's most prestigious institutions, including the University of Michigan, the National Institutes of Health, Cedars-Sinai Medical Center, and UCLA's Charles Drew University of Medicine and Science.
Read Dr. Friedman's First Guest Chat, November 11, 2003.
Read Dr. Friedman's Second Guest Chat, March 2, 2004.

Listen to Dr. Friedman First Live Voice Interview, January 29, 2009.
Listen to Dr. Friedman Second Live Voice Interview, March 12, 2009.
Listen to Dr. Friedman Third Live Voice Interview, February 13, 2011.

Listen live at http://www.blogtalkr...es-for-cushings
Call in to ask your question at
(646) 200-0162
This interview will be archived afterwards at the same link and on iTunes Cushie Podcasts

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FDA approves Korlym for patients with endogenou...

Feb 17 2012 09:45 PM | MaryO in Research and News


For Immediate Release: Feb. 17, 2012
Media Inquiries: Morgan Liscinsky, 301-796-0397; morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Korlym for patients with endogenous Cushing’s syndrome
Today, Korlym (mifepristone) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated) by pregnant women.

Prior to FDA’s approval of Korlym, there were no approved medical therapies for the treatment of endogenous Cushing’s syndrome.

Endogenous Cushing’s syndrome is a serious, debilitating and rare multisystem disorder. It is caused by the overproduction of cortisol (a steroid hormone that increases blood sugar levels) by the adrenal glands. This syndrome most commonly affects adults between the ages of 25 and 40. About 5,000 patients will be eligible for Korlym treatment, which received an orphan drug designation by the FDA in 2007.

Korlym blocks the binding of cortisol to its receptor. It does not decrease cortisol production but reduces the effects of excess cortisol, such as high blood sugar levels.

The safety and efficacy of Korlym in patients with endogenous Cushing’s syndrome was evaluated in a clinical trial with 50 patients. A separate open-label extension of this trial is ongoing. Additional evidence supporting the agency’s approval included several safety pharmacology studies, drug-drug interaction studies and published scientific literature. Patients experienced significant improvement in blood sugar control during Korlym treatment, including some patients who had marked reductions in their insulin requirements. Improvements in clinical signs and symptoms were reported by some patients.

The most common side effects experienced by endogenous Cushing’s syndrome patients treated with Korlym in clinical trials were nausea, fatigue, headache, arthralgia, vomiting, swelling of the extremities, dizziness and decreased appetite. Other side effects of Korlym include adrenal insufficiency, low potassium levels, vaginal bleeding and a potential for heart conduction abnormalities. Certain drugs used in combination with Korlym may increase its drug level. Health care professionals must be aware of the potential for drug-drug interactions and adjust dosing or avoid using certain drugs with Korlym.

Korlym should never be used by pregnant women. Although pregnancy is an extremely rare occurrence in Cushing’s syndrome patients because of the suppressive effect of excess cortisol on female reproductive function, Korlym will carry a Boxed Warning advising health care professionals and patients that the therapy will terminate a pregnancy.

The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is not necessary for Korlym to ensure that the benefits outweigh the risks for patients with endogenous Cushing’s syndrome. Several factors were considered in this determination including the following:
  • There are no other approved medical therapies for this debilitating form of Cushing’s syndrome and very sick patients would suffer if impediments to access were imposed.
  • The number of Cushing’s syndrome patients who will require treatment with Korlym is small, with an estimated 5,000 patients being eligible for treatment.
  • The number of health care professionals in the United States who would potentially prescribe Korlym is very small and highly specialized. They are familiar with the risks of Korlym treatment in the endogenous Cushing’s syndrome population and frequently monitor patient status.
  • The risks of Korlym treatment in the intended population can be managed through physician and patient labeling. The risks associated with Korlym will be outlined in a medication guide for patients.
The company has voluntarily proposed distributing Korlym through a central pharmacy to ensure the timely, convenient and appropriate delivery of the drug to Cushing’s patients or to the health care institutions where this therapy may be initiated. Most retail pharmacies are unlikely to keep adequate supplies of the drug for this rare condition and central distribution will give patients with Cushing’s syndrome better access to Korlym.
Korlym is manufactured by Corcept Therapeutics of Menlo Park, Calif.

For more information:The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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Page Last Updated: 02/17/2012

From http://www.fda.gov/N...s/ucm292462.htm

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More Treatments for Cushing’s Disease

Nov 22 2011 02:54 PM | MaryO in Research and News

(Ivanhoe Newswire) – Cushing's disease is a hormone disorder that causes many symptoms, such as high blood pressure, fat accumulation, osteoporosis and ultimately ending in death. It is caused by a tumor in the anterior pituitary gland that secretes excess amounts of adrenocorticotrophic hormone (ACTH). The only treatment is removal of the tumor, however, researchers have found a new treatment for these reoccurring tumors.

Researchers, led by Shlomo Melmed, at Cedars-Sinai Medical Center, Los Angeles, have now identified a potential new therapeutic target -- the protein EGFR, which is the target of a drug used to treat some patients with non–small cell lung cancer (gefitinib). As discussed by Melmed and colleagues in their paper, as well as Frederic Wondisford, at Johns Hopkins University School of Medicine, Baltimore, in an accompanying commentary, the data generated in human, canine, and mouse models provide strong support to investigate the clinical effects of gefitinib in patients with Cushing disease.

SOURCE: Journal of Clinical Investigation, published online November 21, 2011

From http://www.ivanhoe.c...m?storyid=28468

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Dr. Friedman asked MaryO and I to announce this:

Nov 30 2011 11:39 PM | staticnrg in Research and News

Cushings-Help.com Announces The Availability Of An Investigational Drug ForSevere Cushings's Syndrome On a Compassionate Use Basis

November, 2011
We would like to make patients aware that mifepristone, aninvestigational drug that blocks the action of cortisol and is being developedby Corcept Therapeutics Incorporated, is now available on a compassionate usebasis for eligible patients in the United States with Cushing’s syndrome whohave no other treatment options.

Under this compassionate use program, the FDA allowsseriously ill patients who lack satisfactory alternative treatment options touse an investigational new drug that is still under development. Corcept has completed a Phase III trialinvestigating the safety and efficacy of mifepristone in patients withendogenous Cushing’s syndrome. Theinformation from that study has been submitted to the FDA for review of safetyand efficacy.. For information on thetrial results see http://www.corcept.c...linical_trials. The company has submitted a New DrugApplication (NDA) seeking approval for this drug.

Patients interested in using mifepristone should consultwith their endocrinologist. Theirendocrinologist, in turn, should contact Corcept for information about thecompassionate use program. Please notethat Corcept will provide information solely to physicians.

Toll Free: 1-877-367-6550

Website: www.corcept.com/cushings_expanded_access

E-mail: EAP@Corcept.com

(Edited/changed at 8:54 PM EST by Dr. F's request. He sent another which changes the wording a tiny bit.)

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