Full Press Release Details
ABBOTT PARK, Ill., June 20, 2011 /PRNewswire/ -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved a new 45 mg for six-month administration formulation of Lupron Depot ® (leuprolide acetate for depot suspension), a medication used for the palliative treatment of advanced prostate cancer.
"Lupron Depot is an important treatment option for many patients with advanced prostate cancer," said Eugene Sun , M.D., vice president, Global Pharmaceutical Development, Abbott. "Approval of a new six-month formulation means that physicians and patients who have chosen Lupron Depot now have an additional treatment option."
Patients with advanced prostate cancer who have been prescribed Lupron Depot receive an injection that is administered in the physician office. The three current formulations of Lupron Depot have allowed patients to receive their treatment every month, every three months or every four months. Now, patients who are prescribed the newly approved formulation may receive their treatments every six months, providing additional dosing flexibility for patients with advanced prostate cancer.
Lupron Depot works by suppressing the production of the hormone testosterone. This decrease in testosterone can help slow or stop the growth of hormone-dependent cancer cells, and may relieve pain and other symptoms related to advanced prostate cancer.
Abbott's submission to the FDA was supported by new data from a 48-week, open-label study involving 151 patients with prostate cancer. Patients received a total of two injections, 24 weeks apart, and were followed for nearly one year to evaluate testosterone suppression 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. The most common side effects from this 48-week study were flushing, injection site pain, respiratory infection and fatigue. The 45 mg for six-month administration formulation is expected to be available in late June.
About Prostate Cancer
This year in the United States , more than 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 over the age of 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 .
About Lupron Depot
Lupron Depot belongs to a class of medications known as gonadotropin releasing hormone (GnRH) agonists. Lupron was first approved in 1985 and is the most prescribed GnRH agonist in the United States . In the 26 years since its first approval, Abbott has continued to bring forward new innovations in dosing, administration and support technologies for physicians and patients.
Use for LUPRON DEPOT (leuprolide acetate for depot suspension)
Important Safety Information for LUPRON DEPOT
Full Prescribing Information for Lupron Depot 7.5 mg for 1-month administration is available at http://www.rxabbott.com/pdf/lupron7_5mg.pdf
Full Prescribing Information for Lupron Depot 22.5 mg for 3-month, 30 mg for 4-month and 45 mg for 6-month administration is available at http://www.rxabbott.com/pdf/lupron3_4_6month.pdf
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 nearly 90,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's website at www.abbott.com .