FDA Approves New Formulation of Leuprolide for the Palliative Treatment of Advanced Prostate Cancer

The U.S. Food and Drug Administration (FDA) has approved a new 45 mg six-month administration formulation of leuprolide acetate for depot suspension (Lupron Depot®, Abbott), a medication used for the palliative treatment of advanced prostate cancer. Te existing dosing options currently include one-month, three-month and four-month formulations.

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% 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.

"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."

Leuprolide acetate 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.

Dosing flexibility
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 leuprolide acetate for depot suspension 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.

Decreasing testosterone
Leuprolide acetate for depot suspension 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.

Study results
The 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 2011.

For more information:
- Leuprolide acetate for depot suspension in the palliative treatment of advanced prostate cancer, visit www.prostate.com.
- Full Prescribing Information for Lupron Depot 7.5 mg for 1-month administration About Lupron Depot
- Full Prescribing Information for Lupron Depot 22.5 mg for 3-month, 30 mg for 4-month and 45 mg for 6-month admini....

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Tags: Abbott, FDA, Leuprolide, acetate, cancer, lupron, palliative, prostate

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