Press Release
Abbott Seeks FDA Approval of a New Six-Month 45-mg Formulation of Lupron® Depot for the Palliative Treatment of Advanced Prostate Cancer
March 11, 2010
Abbott Park, Illinois (NYSE: ABT)
— 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.
Media:
Julie Herlocker |
(847) 936-6116 |
Financial:
Lawrence Peepo |
(847) 935-6722 |
