Abbott Seeks FDA Approval of a New Six-Month 45-mg Formulation of Lupron(R) Depot for the Palliative Treatment of Advanced Prostate Cancer

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Mar 11, 2010, 03:08 ET

ABBOTT PARK, Ill., March 11 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron® Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer. Palliative treatment helps to relieve symptoms associated with advanced prostate cancer. Lupron Depot works by suppressing the production of the hormone testosterone. This decrease in testosterone, which helps slow or stop the growth of hormone-dependent cancer cells, may relieve pain and other symptoms related to advanced prostate cancer.

"For many patients with advanced prostate cancer, Lupron Depot is an important treatment option because it can help manage the symptoms of their disease," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "Abbott is seeking approval for a new six-month formulation to provide greater convenience and dosing flexibility to physicians and patients who could benefit from this medication."

Lupron Depot is currently available in one-month (7.5 mg), three-month (22.5 mg) and four-month (30 mg) depot formulations. Abbott's submission is supported by new data from a 48-week study involving 300 patients with prostate cancer. Patients received a total of two injections, 24 weeks apart, and were followed for nearly one year to evaluate efficacy and safety. Overall, testosterone suppression with this new 45-mg six-month depot formulation was sustained in patients throughout the treatment period. The onset of testosterone suppression was consistent with other currently available Lupron Depot formulations.

About Prostate Cancer

This year in the U.S., approximately 200,000 new cases of prostate cancer will be diagnosed. Prostate cancer is the most common type of cancer diagnosed in American men. More than 70 percent of all prostate cancers are diagnosed in men older than 65, and one in six men will be diagnosed with prostate cancer in their lifetime.

For additional information on Lupron Depot for the palliative treatment of advanced prostate cancer, visit www.prostate.com.

Full Prescribing Information for Lupron Depot 7.5 mg is available at

http://www.rxabbott.com/pdf/lupron7_5mg.pdf

Full Prescribing Information for Lupron Depot three-month 22.5 mg is available at

http://www.rxabbott.com/pdf/lupron3month22_5mg.pdf

Full Prescribing Information for Lupron Depot four-month 30 mg is available at

http://www.rxabbott.com/pdf/lupron4month30mg.pdf

About Lupron Depot

Lupron® Depot belongs to a class of medications known as gonadotropin releasing hormone agonists (GnRHa). Lupron was first approved for subcutaneous injection in 1985 and was supported by results from clinical trials which demonstrated the efficacy and safety from daily injections. Lupron Depot 7.5 mg was approved in 1989 followed by Lupron Depot three-month (22.5 mg) and Lupron Depot four-month (30 mg).

Use

Lupron® Depot (leuprolide acetate for depot suspension) 7.5 mg, three-month 22.5 mg and four-month 30 mg are prescribed for the palliative treatment of advanced prostate cancer.

Important Safety Information

Do not take Lupron Depot if any type of allergic reaction to Lupron Depot or similar drugs has been experienced.

Lupron Depot 7.5 mg, – three-month 22.5 mg and – four-month 30 mg should not be used in women.

An increase in testosterone will generally occur during the first few weeks of therapy. In some men, this may cause a temporary increase in urinary symptoms and/or pain. Men with cancer that has spread to the spine or urinary tract may require close medical attention during the first few weeks of therapy. Men should also know that Lupron Depot may cause impotence.

The doctor should be notified if any new or worsened symptoms develop after beginning Lupron Depot treatment.

It is recommended that men have their PSA and serum testosterone levels monitored at regular intervals.

The most common side effects of Lupron Depot include hot flashes or sweats, injection site reactions, general pain, edema, testicular atrophy, urinary disorders, joint disorders and GI disorders.

Lupron Depot must be administered in the doctor's office.

This is the most important information to know about Lupron Depot. For more information, talk with a health care provider.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

SOURCE Abbott