BOSTON, May 15, 2017 /PRNewswire/ -- TOLMAR Pharmaceuticals, Inc. announced today that clinical data from four pivotal trials demonstrate that ELIGARD® (leuprolide acetate for injectable suspension) maintains stable, long-term testosterone (T) suppression. ELIGARD, indicated for the palliative treatment of advanced prostate cancer, is the only luteinizing hormone releasing hormone (LHRH) agonist employing the innovative controlled-release ATRIGEL® Delivery System. The data were presented in a moderated poster presentation at the 112th Annual American Urological Association Meeting in Boston (MP57-17).
"Serum level of leuprolide acetate (LA) required to achieve and maintain low T levels has not been previously established," said presenting author Christopher Pieczonka, MD, Director of Research, Associated Medical Professionals of NY. "These data clearly demonstrate that across the approved 1-, 3-, 4-, and 6-month doses, subcutaneously delivered ELIGARD consistently achieves prolonged drug delivery, and leuprolide levels above 0.1 ng/mL are associated with long-term, favorable T suppression."
Additional data highlights
- For all formulations (1-, 3-, 4-, and 6-month), median serum LA levels remained consistent at levels of approximately 0.1ng/mL or higher throughout each of the dosing intervals
- Over the course of the four studies, 88% of patients reached a nadir T ≤ 5 ng/dL with a median nadir T of 3.5 ng/dL
- Low levels of microsurges (<25 mg/dL T increase within 4 weeks after a second injection) were seen; 0.9%-2.3% across studies
"Presentation of these data at the 112th Annual American Urological Association Meeting here in Boston further reinforces our company legacy of science and data, and the role ELIGARD can play in the management of patients with advanced prostate cancer," said Susan Rodriguez, CEO of TOLMAR Pharmaceuticals.
For additional details please visit TOLMAR Pharmaceuticals at AUA Booth #2415.
About TOLMAR Pharmaceuticals and ELIGARD
TOLMAR is a fully integrated pharmaceutical company focused on the development, approval, manufacturing, and commercialization of specialty pharmaceutical products. TOLMAR Pharmaceuticals' US commercial business is based in Lincolnshire, Illinois, with TOLMAR global headquarters, product development, and manufacturing facilities based in Northern Colorado. TOLMAR Pharmaceuticals has the exclusive distribution rights for ELIGARD in the US and Puerto Rico. ELIGARD is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer, developed and manufactured by TOLMAR Inc. "TOLMAR" refers to TOLMAR Holding Inc. and its wholly owned operating subsidiaries, TOLMAR Inc., TOLMAR Therapeutics, Inc., and TOLMAR Pharmaceuticals, Inc. For more information about the company, please visit www.tolmar.com. Information about ELIGARD is available at www.eligard.com.
Important Safety Information for ELIGARD® (leuprolide acetate for injectable suspension)
ELIGARD is a medicine for managing advanced prostate cancer. It is not a cure for advanced prostate cancer. ELIGARD should not be used by anyone who is allergic to any drug that is in the same class as ELIGARD, or anyone who is allergic to any of the ingredients in ELIGARD. A severe and possibly life-threatening allergic reaction called anaphylaxis has been known to happen when people receive ELIGARD and other drugs in its class. Women who are pregnant or may become pregnant should not use ELIGARD. ELIGARD can cause pregnancy loss or harm an unborn baby when used by a pregnant woman. Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving ELIGARD and other drugs in its class. Your doctor will monitor your blood sugar levels. Increased risk of heart attack, sudden death due to heart attack, and stroke also has been reported in men using drugs in ELIGARD's class. Your doctor will monitor you for heart disease. ELIGARD may also prolong the QT/QTc interval, which can cause a certain type of irregular heartbeat. Your doctor will talk to you about the risks and benefits of taking ELIGARD. The most common injection site adverse events are temporary burning and stinging, pain, bruising, and redness. The most common systemic adverse events include mild to severe hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess, testicular shrinkage, and enlarged breasts. Other adverse reactions have been reported with drugs in ELIGARD's class. These include reduced bone density and rare but serious problems involving the pituitary gland.
Please see full Prescribing Information for additional important safety information.
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SOURCE TOLMAR Pharmaceuticals, Inc.