Korlym™ (mifepristone), the First Approved Medication for Patients with Endogenous Cushing’s Syndrome, to be Available by April 11

Corcept Therapeutics (NASDAQ:CORT) announced that it would be ready to ship Korlym to patients by April 11th, three weeks ahead of the company’s previously announced launch date. “Cushing’s syndrome is a life altering and life threatening disease,” said Joseph K. Belanoff, M.D., the company’s Chief Executive Officer. “We have worked hard to bring this first-in-class treatment to patients as quickly as possible.”

On February 17, 2012, the U.S. Food and Drug Administration (FDA) approved KorlymTM (mifepristone) 300 mg Tablets as a once-daily oral medicine to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Physicians and patients seeking more information can visit http://www.korlym.com.

Korlym is distributed in 300 milligram tablets to be taken once each day. The wholesale acquisition price of Korlym is $0.62 per milligram. The FDA-approved labeling instructs physicians to titrate each patient’s Korlym dose to clinical efficacy by assessing tolerability and degree of improvement in Cushing’s syndrome manifestations. In the first six weeks, these manifestations may include changes in glucose control, anti-diabetic medication requirements, insulin levels and psychiatric symptoms. After two months, assessment may also be based on improvements in cushingoid appearance, acne, hirsutism, striae or decreased body weight, along with further changes in glucose control.

Patient Assistance Programs 
“Our highest priority is that every patient who is prescribed Korlym will receive it,” said Dr. Belanoff. To that end, the company has launched a comprehensive financial assistance and patient support program. A dedicated team of Corcept case managers will help patients understand their insurance benefits and the financial and medical support programs available to them.

“Patients face tremendous challenges managing their illness – from finding physicians familiar with the disease to navigating the complexities of insurance reimbursement to paying for the cost of care,” said Dr. Belanoff. “We are determined that none of these barriers will keep patients from receiving the benefits of Korlym.”

About Cushing’s Syndrome 
Endogenous Cushing’s syndrome is a rare and life-threatening endocrine disorder that results from long-term exposure to excess levels of the hormone cortisol. This excess is caused by tumors that usually occur in the pituitary or adrenal glands that over-produce, or prompt the over-production of, cortisol.

Although cortisol at normal levels is essential to health, in excess it causes a variety of problems, including hyperglycemia, upper body obesity, a rounded face, stretch marks on the skin, an accumulation of fat on the back, thin and easily bruised skin, muscle weakness, bone weakness, persistent infections, high blood pressure, fatigue, irritability, anxiety, psychosis and depression. Women may have menstrual irregularities and facial hair growth, while men may have decreased fertility or erectile dysfunction. More than 70 percent of Cushing’s syndrome patients suffer from glucose intolerance or diabetes.

The treatment of an endogenous Cushing’s syndrome patient depends on the cause. The first-line approach is surgery to remove the tumor. If surgery is not successful or is not an option, radiation may be used, but that therapy can take up to ten years to achieve full effect. Surgery and radiation are successful in only approximately one-half of all cases.

If left untreated, Cushing’s syndrome has a five-year mortality rate of 50 percent.

An orphan disease, Cushing’s syndrome occurs in about 20,000 people in the United States, mostly women between the ages of 20 and 50.

About Korlym™ (mifepristone) 300 mg Tablets
Korlym is a once-daily oral medication that blocks the glucocorticoid receptor type II (GR-II) to which cortisol normally binds. By blocking this receptor, Korlym inhibits the effects of excess cortisol in Cushing’s syndrome patients.

The FDA has designated Korlym as an Orphan Drug, a special status designed to encourage the development of medicines for rare diseases and conditions. Because Korlym is an Orphan Drug, Corcept will have marketing exclusivity for the FDA-approved indication until February 2019.

IMPORTANT SAFETY INFORMATION


WARNING: TERMINATION OF PREGNANCY

 

See full prescribing information for complete boxed warning.

 

Mifepristone has potent antiprogestational effects and will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym, or if treatment is interrupted for more than 14 days in females of reproductive potential.

 

Contraindications

  • Pregnancy
  • Use of simvastatin or lovastatin and CYP 3A substrates with narrow therapeutic range
  • Concurrent long-term corticosteroid use
  • Women with history of unexplained vaginal bleeding
  • Women with endometrial hyperplasia with atypia or endometrial carcinoma

Warnings and Precautions

  • Adrenal insufficiency: Patients should be closely monitored for signs and symptoms of adrenal insufficiency.
  • Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment.
  • Vaginal bleeding and endometrial changes: Women may experience endometrial thickening or unexpected vaginal bleeding. Use with caution if patient also has a hemorrhagic disorder or is on anti-coagulant therapy.
  • QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval.
  • Use of Strong CYP3A Inhibitors: Concomitant use can increase plasma levels significantly. Use only when necessary and limit dose to 300 mg.

Adverse Reactions

Most common adverse reactions in Cushing’s syndrome (≥ 20%): nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, endometrial hypertrophy.

To report suspected adverse reactions, contact Corcept Therapeutics at 1-855-844-3270 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

  • Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym
  • CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Limit mifepristone dose to 300 mg per day when used with strong CYP3A inhibitors.
  • CYP3A inducers: Do not use Korlym with CYP3A inducers.
  • Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym.
  • Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion and efavirenz.
  • Hormonal contraceptives: Do not use with Korlym.

Use in Specific Populations

  • Nursing mothers: Discontinue drug or discontinue nursing.

Please see the accompanying full Prescribing Information including boxed warning atwww.corcept.com/prescribinginfo.pdf

Please see the accompanying Medication Guide at www.corcept.com/medicationguide.pdf

About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders. Korlym, a first generation GR-II antagonist, is the company’s first FDA-approved medication. The company has a portfolio of new selective GR-II antagonists that block the effects of cortisol but not progesterone. Corcept also owns an extensive intellectual property portfolio covering the use of GR-II antagonists, including mifepristone, in the treatment of a wide variety of psychiatric and metabolic disorders. The company also holds composition of matter patents for its selective GR-II antagonists.

Statements made in this news release, other than statements of historical fact, are forward-looking statements. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. For example, there can be no assurances that clinical results will be predictive of real-world use, or regarding the pace of Korlym’s acceptance by physicians and patients, the reimbursement decisions of government or private insurance payers, the effects of rapid technological change and competition, the protections afforded by Korlym’s Orphan Drug Designation or by Corcept’s other intellectual property rights, and the cost, pace and success of Corcept’s other product development efforts. These and other risks are set forth in the Company’s SEC filings, all of which are available from our website (www.corcept.com) or from the SEC’s website (www.sec.gov). We disclaim any intention or duty to update any forward-looking statement made in this news release.

CONTACT:

 

Investor Contact
Charles Robb
Chief Financial Officer 
Corcept Therapeutics
650-688-8783

Dr. Theodore Friedman Will Return April 2

Dr. Theodore Friedman Will Return April 2

Dr. Theodore Friedman Will Return April 2, 2012

Have questions about thyroid issues?

Ask Dr. Theodore Friedman.

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 to Dr. Friedman Fourth Live Voice Interview, March 12, 2012.

Dr. Friedman will return April 2, 2012.  The call in number with questions or comments is (646) 200-0162.

Listen live at http://www.blogtalkradio.com/cushingshelp

This interview will be archived afterwards at the same link and on iTunes Cushie Podcasts

 

Single-Incision Transperitoneal Laparoscopic Left Adrenalectomy

Óscar Vidal, Emiliano Astudillo, Mauro Valentini, Cesar Ginestà, Juan C. García-Valdecasas and Laureano Fernandez-Cruz

 

 

Abstract

Background  

Laparoscopic adrenalectomy via three or four trocars is a well-established procedure. This report describes the initial experience with single-incision laparoscopic surgery (SILS) using the transperitoneal approach for left adrenalectomy.

Methods

Between April 2010 and August 2011, all consecutive patients with adrenal masses, including Conn’s syndrome, Cushing’s adenoma, and nonfunctional adrenal tumors, who agreed to undergo SILS adrenalectomy were included in a prospective study. The left 2.5-cm subcostal incision was the sole point of entry. Data of patients who underwent SILS adrenalectomy were compared with those from an uncontrolled group of patients who underwent conventional laparoscopic adrenalectomy during the same study period.

Results

There were 20 patients in each study group (20 men, 20 women; mean age [SD] = 50 [6.5] years). SILS was successfully performed and none of the patients required conversion to an open procedure. In one case of SILS procedure, an additional lateral 5-mm port was needed for retraction of the kidney. The mean (SD) duration of the operation was 95 (20) min in the SILS group and 80 (8) min in the conventional laparoscopic adrenalectomy group (p = 0.052). There were no intraoperative or postoperative complications. There were no differences between the two study groups with respect to postoperative pain, number of patients who resumed oral intake within the first 24 h, final pathologic diagnosis, and length of hospital stay.

Conclusion  

SILS left adrenalectomy is a technically feasible and safe procedure in carefully selected patients. The definitive clinical, aesthetic and functional advantages of this technique require further analysis.

 

 

 

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From http://www.springerlink.com/content/h60075322750m0x0/

 

New drug shows promise in patients with rare illness

Two in Montreal with Cushing’s disease were among 16 in international trial

By AARON DERFEL, The Gazette

Quebecers suffering from Cushing’s disease – a rare hormonal disorder – have some reason to be hopeful after a clinical trial conducted partly in Montreal has shown promising results of a new drug.

About 400 to 500 Quebecers have Cushing’s disease or syndrome, a disorder that produces tumours on the pituitary gland, leading to a spike in cortisol levels.

The excess cortisol can cause a wide range of problems, including obesity, hypertension and diabetes as well as sleep and mood disorders.

In some people, deposits of fat accumulate on the back of the neck and shoulders, an effect known as a “buffalo hump.”

Until now, surgery and radiotherapy have been the only options for many patients. However, a drug developed by Novartis Pharmaceuticals has been found to act on the tumours, cutting cortisol levels an average of 50 per cent.

In some patients – two of them from Quebec – cortisol levels returned to normal.

The drug, pasireotide, involves twice-daily injections. The treatment has yet to be approved by Health Canada.

“This study is very promising, especially for patients for whom complete surgical removal of tumours – the standard treatment for this disease – was not possible,” said Dr. André Lacroix, an endocrinologist at the Centre hospitalier de l’université de Montréal.

Lacroix and his colleagues tested the drug on four patients. In addition to the two who “experienced a complete regression of all symptoms” of Cushing’s disease, the two others reported drops in their cortisol levels and an improvement in their health, Lacroix noted.

The findings of the international study of 16 patients were published in the latest edition of the New England Journal of Medicine.

Pasireotide acts by binding to certain receptors on the tumours. Lacroix’s team has also carried out a separate study of another drug that targets a different receptor.

He suggested that using the two drugs together might prove even more beneficial, but this must be borne out by further research.

The ideal patients for the drug therapy would be those whose tumours are too small for surgery, Lacroix said.

Each year in Quebec, there are about 15 new cases of Cushing’s disease, and doctors at the CHUM treat about 150 patients.

aderfel@montrealgazette.com

© Copyright (c) The Montreal Gazette

 

 

Read more: http://www.montrealgazette.com/health/
drug+shows+promise+patients+with+rare+illness/6340316/story.html

 

 

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