Abbott receives FDA approval for a new six-month formulation of Lupron Depot®

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)

• LUPRON DEPOT 7.5 mg for 1-month, 22.5 mg for 3-month, 30 mg for 4-month, and 45 mg for 6-month administration are prescribed for the palliative treatment of advanced prostate cancer.
• LUPRON DEPOT is a prescription medication that must be administered in the doctor’s office.

Important Safety Information for LUPRON DEPOT

• LUPRON DEPOT is not for people who have had any type of allergic reaction to LUPRON DEPOT or similar drugs.
• LUPRON DEPOT is not for women who are or may become pregnant.
• LUPRON DEPOT causes an increase in testosterone during the first few weeks of therapy.
  • Some men may experience temporary new or worsening symptoms of prostate cancer, including urinary symptoms and/or bone pain.
  • For men with cancer that has spread to the spine or urinary tract, urinary blockage or pressure in the spine may occur that can sometimes lead to paralysis, which may be life-threatening.
  • Patients may require close medical attention during the first few weeks of therapy. The doctor should be notified if new or worsened symptoms develop after beginning LUPRON DEPOT treatment.
• Regular blood tests are needed to check testosterone and PSA levels.
• High blood sugar and increased risk of diabetes can occur in men using LUPRON DEPOT. The doctor will monitor blood sugar during treatment.
• Increased risk of heart attack, sudden death, and stroke can occur in men using LUPRON DEPOT. These increased risks and any new symptoms during treatment should be discussed with the doctor.
• Long-term use of LUPRON DEPOT can affect the heart’s electrical activity. A doctor must determine if the benefits of using LUPRON DEPOT outweigh the risks, especially in patients with congenital long QT syndrome, abnormal blood tests for electrolytes, or congestive heart failure, or who take medications to regulate the heartbeat.
• LUPRON DEPOT may cause impotence.
• The most common side effects of LUPRON DEPOT include hot flashes/sweats, injection site reaction/pain, general pain, swelling, testicular shrinkage, difficulty urinating, fatigue/weakness, headache, and joint, GI, and respiratory problems.

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